ML20205F231

Forwards Proposed Amends to Commission Rules in 10CFR50, 52 & 72 in Order to Make Regulations More Consistent with Original Objectives of Change Control Mechanisms in Rules While Proposed Regulations Will Reduce Licensee Burden

ML20205F231
Person / Time
Issue date:	03/29/1999
From:	Lohaus P NRC OFFICE OF STATE PROGRAMS (OSP)
To:	GENERAL
References
NUDOCS 9904060147
Download: ML20205F231 (30)

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{{#Wiki_filter:- STATE LIAISON OFFICERS M 2 8 1993 PROGRAM MANAGEMENT INFORMATION: PROPOSED RULEMAKING ON 10 CFR PARTS 50,52 AND 72 REQUIREMENTS CONCERNING CHANGES, TESTS AND EXPERIMENTS AND STAFF RECOMMENDATIONS ON CHANGES TO OTHER REGULATIONS AND ENFORCEMENT POLICY The United States Nuclear Regulatory Commission (NRC) has published in the Federal Reaister the enclosed proposed amendments to the Commission's rules in 10 CFR Parts 50, 52, and 72. These amendments have been proposed in order to make NRC's regulations more consistent with the original objectives of the change control mechanisms in these rules while continuing to furnish an adequate level of protection to the public health and safety. These proposed regulations will reduce licensee burden by providing more flexibility to implement changes to their facilities and operations without obtaining prior NRC approval. In addition to providing organizational and structural changes to the regulations, these amendments would (1) provide clarifying definitions of terms such as " change" and " facility" (2) clarify that a license amendment must be sought for changes that do require prior NRC - approval, (3) provide seven criteria for the making of a determination that prior NRC approval is required, (4) revise the definition of independent spent fuel storage installation, and make other conforming changes to the regulations. The Environme6,tal Assessment (EA) is contained in the Statement of Consideration. The conclusion of the EA is the Commission's finding that no significant environmentalimpact will result from the proposed rule. The Federal Reaister Notice is provided for your review and comment. Since we did not transmit these materials to you at the time the rule was published, I am requesting that, if you have any comments on the rule and its environmental impact, you i please send them by April 21,1999. Comments received after this date will be considered if it is practical to do so, but the staff is able to assure cons lderation only for comments received by April 28,1999. Also enclosed for your consideration is SECY-99-054. This Commission paper presents the staff's preliminary views concerning the final rule language as well as a summary of the public comments submitted. / You can use the following methods to transmit your comments: (1) you can mail your written 'j/ comments to: Secretary, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001, [ Attention Rulemakings and Adjudications Staff; (2) you can fax your comments to 301-415-1672, or (3) you may submit your comments via NRC's external website at the following URL location: http://ruteforum.lini.aov/cai-bin /rulemake and select the subject rule. Sincerely, C ~3 - OlloinalSignedBy: h;3 k h b P ILo a ctor Office of State Programs

Enclosures:

9904060147 990329 PDR STPRG ESGGEN As stated PDR Distribution:

gQ2, DIR RF DCD (SP03)

EMcKenna, NRR PDR (YES/) HTovmassion, NRR SLO Gen File

• See previous concurrence.

DOCUMENT NAME: G:\\SCD\\ LIAISON.WPD Ti receive a cop f of this document, Indicate in the bex: *C" = 0 y1i at attachment / enclosure "E" = Copy with attachment / enclosure "N" = No copy IOFFICE OSP l OSP% h l l l l NAME SCDroggitis:gd PHLobath ' ' DATE 03/29/99* 03d/99 OSP FILE CODE: SP-S-9 a

STATE LIAISON OFFICERS. PROGRAM MANAGEMENT INFORMATION: PROPOSE RULEMAKING ON 10 CFR PARTS 50,52 AND 72 REQUIREMENTS CONC RNING CHANGES, TESTS AND EXPERIMENTS AND STAFF RECOMMENDAT!O ON CHANGES TO OTHER REGULATIONS AND ENFORCEMENT POLICY The United States Nuclear Regulatory Commission (Nip) has published in the Federal Reaister the enclosed proposed amendments to the Commission's rules in 10 CFR Parts 50, 52, and 72. These amendments have been proposed p order to make NRC's regulations more consistent with the original objectives of the change control mechanisms in these rules and to reduce licensee burden by providing more flexibility to implement changes to their facilities and operations without obtaining prior NRC approval. In addition to providing organizational and structural c; anges to the regulations, these amendments would (1) p. ovide clarifying definitions of terms such as " change" and " facility as described...," (2) clarify that a license amendment,must be sought for changes that do require prior NRC approval, (3) provide seven criteria for the making of a determination that prior NRC approval is required, (4) revise the definition of independent spent fuel storage installation, and licensees more flexibility to make unilateral change ls to their plant and proced continuing to furnish an adequate level of protection to the public health and safety. l The Environmental Assessment (EA) is contained in the Statement of Consideration. The conclusion of the EA is ite Commission's finding,that no significant environmental impact will result from the proposed rule. The Federal Reaister Notice is provided for your review and commeic. Since we failed to transmit these materials to you at the time the rule was published, I am requesting that, if you have any comments lon the rule and its environmental impact, you I please send them by April 21,1999. Comments received after this date will be considered if it is practical to do so, but the Commission is able to assure consideration only for comments received by April 28,1999. Also enclosed for your consideration is SECY-99-054. This Commission paper presents the staff's preliminary views concerning the final rule language as well as a summary of the public comments submitted. / You can use the following methods to transmit your comments: (1) you can mail your written comments to: Secretary, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001, Attention Rulemakings and Adjudications Staff; (2) you can fax your comments to 301-415-1672, or (3) you may submit your comments via NRC's external website at the - following URL location: http://ruleforum.llnl.aov/cai-bin /rulemake and select the subject rule. i Sincerely, Paul Lohaus, Director Office of State Programs

Enclosures:

As stated Distribution: DIR RF-DCD (SP03) EMcKenna, NRR PDR (YES/) HTovmassion, NRR - SLO Gen File DOCUMENT NAME: G:\\SCD\\ LIAISON.WPD To receive e cop r of this document, indicate in the box: "C" = Copy attachment / enclosure "E" = Copy with attachment / enclosure *N' = No copy OFFICE $b OSP l OSP:D ! l l l NAME SCDroggitis:gd PHLohaus I DATE 03/fV99 03/ /99 j OSP FILE CODE: SP-S-9 h

=- g -3 UNITED STATES s j-NUCLEAR REGULATORY COMMISSION 'g WASHINGTON, D.C. 20066 4 001 %g *o March'29, 1999 STATE LIAISON OFFICERS PROGRAM MANAGEMENT INFORMATION: PROPOS. D RULEMAKING ON E 10 CFR PARTS 50,52 AND 72 REQUIREMENTS CONCERNING CHANGES, TESTS AND EXPERIMENTS AND STAFF RECOMMENDATIONS ON CHANGES TO OTHER . REGULATIONS AND ENFORCEMENT POLICY The United States Nuclear Regulatory Commission (NRC) has published in the Eederal Reaister the enclosed proposed amendments to the Commission's rules in 10 CFR Parts 50, 52, and 72. These amendments have been proposed in order to make NRC's regulations more consistent with the original objectives of the change control mechanisms in these rules while continuing to fumish an adequate level of protection to the public health and safety. These proposed regulations will reduce licensee burden by providing more flexibility to implement - changes to their facilities and operations without obtaining prior NRC approval, in addition to providing organizational and structural changes to the regulations, these amendments would (1) provide clarifying definitions of terms such as " change' and " facility" (2) clarify that a license amendment must be sought for changes that do require prior NRC approval, (3) provide seven criteria for the making of a determination that prior NRC approval is required, (4) revise the definition of indep sndent spent fuel storage installation, and make other conforrring changes to the regulations. ' The Environmental Assessment (EA) is contained in the Statement of Consideration. The conclusion of the EA is the Commission's finding that no significant environmental impact will result from the proposed rule. The Federal Reaister Notice is provided for your review and comment. Since we did not transmit these materials to you at the time the rule was published, I am requesting that, if you have any comments on the rule and its environmental impact, you please send them by April 21,1999. Comments received after this date will be considered if it is practical to do so, but the staff is able to assure consideration only for comments received by April 28,1999. Also enclosed for your consideration is SECY-99-054. This Commission paper presents the staff's preliminary views concerning the final rule language as well as a summary . of the public comments submitted. You can use the following methods to transmit your comments: (1) you can mail your written comments to: Secretary, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001, Attention Rulemakings and Adjudications Staff; (2) you can fax your comments to 301-415-1672, or (3) you may submit your comments via NRC's external website at the following URL location: htto://ruleforum.llnl.aov/ctdin/rulemake and select the subject rule. Si cerely, T , {p Paul Lohaus, Director Office of State Programs

Enclosures:

As stated i l

} 56098 - Federil Regist;r/Vol. 63, No. 203/Wednisday, October 21,1998/ Proposed Rules the exposure and frequency of this NUCLEAR REGULATORY C. Change to the procedures as described varietal designation will also increase. COMMISSION in the Safety Analysis Report Since the purpose of these standards is D. Tests and experiments not described in to expedite the marketing of agricultural 10 CFR Parts 50,52 and 72 the Safety Analysis Report E. Safety Analysis Report commodities, not changing this mN 3150-AF94 F. Probability of occurrence or reference could result in confusion in consequences of an accident or terms of the proper application of the Changes, Tes's, and Experiments malfunction of equipment important to U.S. grade standards. This proposed action will make the GE CY Nuclear Re8ulato'Y safety previously evaluated in the safety ) Commission. analysis report may be increased standards more consistent and uniform C. More than a minimalincrease in ACTION: Proposed rule, probability or consequences with marketing trends and commodity H. Possibility of an accident of a different characteristics. This proposed action

SUMMARY

The Nuclear Regulatory will not impose any additional reporting Commission is proposing to amend its fh Safe y A j

ys s e rt may or recordkeeping requirements on either regulations concerning the authority for created j small or large grape producers, licensees of production or utilization I. Possibility of a malfunction of a different handlers, or importers. In addition-facilities, such as nuclear reactors, and type from any previously evaluated in other than discussed above, the independent spent fuel storage facilities, the Safety Analysis Report may be Department has not identified any to make changes to the facility or created Federal rules that duplicate, overlap, or procedures, or to conduct tests or J. Margin of safety as defined in the basis conflict with this rule. Accordingly-experiments, without prior NRC f r any technical specification is Reduced AMS proposes to amend the United approval. The proposed rule would Sa ty Evaluauon States Standards for Grades of Table clarify which changes, tests and P na Grapes (European or Vinifera Type) as experiments conducted at a licensed re ns follows. facility require evaluation, and the M. Part 72 changes List of Subjects in 7 CFR Part 51 criteria that determine when NRC

m. Section by Section Analysis j

approval is needed before such changes IV. Commission Voting Record on SECY Agricultural commodities. Food to a licensed facility can be 171 grades and standards. Fruits. Nuts-implemented. The proposed rule would V. Rule Language Proposed by the Nuclear Reporting and recordkeeping also add definitions for terms that have Energy Insutute i requirements. Trees, Vegetables. been subject to differing interpretations. VI. Request for Public Comments For reasons set forth in the preamble, reorganize the rule language for clarity, YII' Ayl1 ability of Documen's and Electronic 7 CFR Part 51 is proposed to be and revise the criteria for when prior VIII. Finding of No Significant amended as follows: NRC approval is needed. The EnvironmentalImpact Commission is also seeking comment on IX. Paperwork Reduction Act Statement PART 51-{ AMENDED) several specific issues as discussed X. Regulatory Analysis below. XI. Regulatory Flexibility Certification I.The authority citation for part 51 Bac i na s continues to read as follows: DATES: Submit comments by December 21,1998. Comments received after this p Authority: 7 U.S.C.1621-1627. date will be considered if it is practical XIV. Compatibility Agreement State 'E" '" "' $ 51.882 (Amended] to do so, but the Commission is able to assure c nsideration only for comments I. Background

2. In Part 51 S 51.882 (1)(1)(11) is received on or before this date.

amended by removing the words The existing requirements governing DRESS S Sen com the authority of production and " Superior Seedless" and adding in their place the word Sugraone. , 9 a u ory utilization facilit licensees to make Commission, Washington, DC 20555-I 51.884 [ Amended] 0001. ATTN: Rulemakings and c an8 $ het sa ed ne

3. Section 51.884 (1)(1)(1) is amended Ad ca "

d Iver o ments to 11555 experiments, without prior NRC by removing the words Superior Seedless and adding in their place Rockville Pike, Rockville, Maryland approval are contained in 10 CFR 50 9 l Sugraone. between 7:45 a.m. and 4:15 p.m. Federal (Comparable provisions exist in 10 Ci a 72.48 for licensees of facilities for the workdays. independent storage of spent nuclear 551.885 (Amended} FOR FURTHER INFORMATION CONTACT:

4. Section 51.885 (h)(1)(1) is amended Eileen McKenna, Office of Nuclear fuel and high. level radioactive waste.

by removing the words " Superior Reactor Regulation, U.S. Nuclear 5[#P$d e "8 h ents 0 CF pa s S2 Seedless" and adding in their place Regulatory Commission. Washington, "Sugraone." DC 20555-0001, telephone (301) 415-and 72; for simplicity, the discussion will focus primaril on the language in Y 2189. (emm@nrc. gov) or Naiem Tanious. $ 51.888 [ Amended) Office of Nuclear Materials Safety and 10 CFR 50.59). These regulations

5. In S 51.888, paragraph (a)(2), the Safeguards. U.S. Nuclear Regulatory

[,7,Vnges to th fa 11 r pr cedures as words " February 28,1992" are revised Commission. Washington DC 20555-to read November 16.1996. 0001, telephone (301) 415-6103 described in the safety analysis report, Sated: October 15,1998. (nst@nrc. gov). or conduct tests or experiments not described in the safety analysis report, SUPPLEMENTARY INFORMATION: Robert C. Keeney, without prior Commission approval. Deputy Administrator, Fruit and Vegetable fj,BPro ed ule Topics and Issues unless the proposed change, test or Programs. A. Organization of the rule requirements experiment involves a change to the JFR Doc. 98-28238 Filed 10-20-98; 8:45 aml B. Change to the facility as described in the Technical Specjrications incorporated DE.UNG CODE WD 00-P Safety Analysis Report in the license or an unreviewed safety

l ) Fed:rcl Regist:r/Vol. 63. No. 203/Wedn sday, October 21,1998/ Proposed Rules 56099 l question. Section 50.59(a)(2), as regulations and with requirements with the design and operating limits) of ) currently codified. states: contained in the license. The license instrument drift or error, temperature. describes the facility in general terms, pressure, fluid volume and enthalpy, and includes specific conditions flow rate system response time, heat sha d ed in e n e safety question (i) if the probability of imposed on the facility and the licensee, transfer rate and heat capacity. l occurrence or the consequences of an as well as incorporates the TS. Section reactivity coefficients, power history acident or malfunction of equipment 50.36 of the regulations defines for and decay heat. An FSAR analysis also important to safety previously evaluated in inclusion in the TS those limits and typically assumes the worst-case single-the safety analysis report may be increased; parameters of most immediate active failure of equipment. l or (ii) if a possibility for an accident or significance for protection of public National standards and other malfunction of a different type than any health and safety: safety limits, limiting regulatory policies, such as defense-in-evaluated previously in the safety analysis report may be created; or (111) if the margin safety sy< tem settings, limiting depth, constitute additional engineering conditions for operation, surveillance considerations that influence plant requirements, and design features to design and operation. Commensurate ec al f cati n s r u which changes would have a significant with expected frequency and The rule also specifies record keepin8 effect on safety, and administrative consequences of challenges to the and reporting requirements associated controls. The TS are derived from the system, defense in-depth could require: with such changes tests or experiments. safety analysis, evaluations, and design (1) Multiple n.eans to accomplish safety In order to understand the reasons for bases described in the FSAR. Any functions and prevent release of 1 the provisions of the current rule, and changes to the TS must receive NRC radioactive material (multiple barriers): I how the Commission proposes to revise review and approval before they are (2) reasonable balance among it. It is helpful to understand how this

made, prevention of core damage, prevention process fits within the overall Engineering evaluations demonstrate of containment failure and consequence requirements undergirding licensing that the fundamental safety principles of mitigation: (3) system redundancy: (4) and oversight of nuclear reactors.

the plant design are met. Design basis independence; and (5) diversity. Overview o/ Licensing Process events play a central role in plant Various margins exist an a facility design. These are a combination of design. These margins are based on, for The application for an operating postulated challenges and failure events, example, assumptions of initial license includes the final safety analysis against which plants are designed to conditions, consesvatisms in computer report (FSAR) which is to contain: a ensure adequate and safe plant modeling and codes, allowance for description of the facility; the design response. Design basis events are instrument drift and system response bases and limits on operation; and the defined as conditions of normal time, redundancy and independence of safety analysis for the structures, operation, anticipated operational components in safety trains, and plant systems. and components fiSC) and of occurrences and design basis accidents. response during operating transient and the facility as a whole.The safety external events and natural phenomena accident conditicns. Margin is provided l analysis emphasizes performance for which the plant has been designed by meeting codes and standards or requirernents, analytical bases and to ensure the integrity of the pressure alternatives approved for use by NRC. technicaljustifications, and evaluations boundary, the capability to shutdown including the safety analysis acceptance that show how safety functions will be safely, and the capaollity to prevent or criteria in the FSAR and in supporting accomplished. Design bases include the mitigate the consequences of accidents. analyses. Not all margin that exists falls specific functions that the SSC need to For events with high frequency. NRC within the purview of " reduction in perform, the parameters that need to be requires that consequences be low (such margin of safety I as defined in the basi <. controlled to assure the function, and as by preventing fuel damage). For more for any technical specification." the range of values for these parameters. severe, but less probable accidents. the When a plant is licensed, the NRC As part of the FSAR the applicant is allowable consequences are higher, but states in its Safety hvaluation Report required to propose, for NRC approval. must still meet the regulatory guidelines (SER) why it found each FSAR arsalysis Technical Specifications (TS) that will established in 10 CFR part 100. acceptable. An FSAR analysis may be become part of the license. Adequacy of the reactor design is accepted because it was considered to i The NRC issues a license after evaluated by consideration of postulated be adequately conservative and because j finding. among other things, that the des.lgn basis events viewed a5 the NRC's acceptance criteria for that plant has been built according to its sufficiently credible that the facility analysis are met. Frequently, the SER l design and can be operated within its should be designed to prevent or states specific conditions the NRC relied design limits. The NRC prepares a safety mitigate their effects, upon for concluding that the analysis evaluation report that documents the During the design process, plant was conservative. Examples of such l basis for its findings, including its response is evaluated using assumptions conditions may be the use of an NRC-l review of the design information that are intended to be conservative to approved computer code, correlation, or provided in the FSAR (and eupporting account for uncertainties in analysis or setpoint methodology, specific documents) and the appl. cable data. In the Final Safety Analysis Report limitations on one or more input acceptance criteria (established either in (FSAR). analyes are done assumptions, or penalties put into a regulations. standards or guidance conservatively to account for calculation to account for uncertainties. documents). In some cases, the NRC uncertainties in the design. In addition to being stated in a plant-staff performs independent analyses to construction, and operation of nuclear confirm the adequacy of the facility power plants. These conservatisms are ' Margin or sarety is not defined in the design to meet regulatory requirements. Introduced into FSAR analyses in regulations. although it is mentioned in 5 50 34(a) One example of this practice is the staff numerous ways. For example some ("the margins or safety during normal operauons calculation of radiological consequences coinputer codes model systems and pd ir , con,d te ns .,i ed dunng lire t (doses) for design basis accidents. processes in a simplified but bounding considerations if the proposed amendment would The licensee is required to operate the fashion. Analysis input assumptions are not involve a signincant reducnon in a margin or f:cility in accordance with NRC typically worst case values (consistent sarety7 as wen as 5 50.st i

56100 Feder:.1 Registir/Vol. 63. No. 203/Wedn:sday, October 21,1998/ Proposed Rules i specific SER, these conditions may be Implementation Guidance proposed guidance, the staff compared i found in other safety evaluations such in 1989, an industry guidance its proposed regulatory guidance to cs for an analysis method proposed by document. NSAC-125. " Guidelines for industry Euldance contained in NSAC-e topical report. 10 CFR 50.59 Safety Evaluations" was 125. In accordance with a Commission Changes to the basis for licensing published to assist licensees in the Staff Requirements Memorandum dt.ed l occur over the life of the plant through conduct of the evaluations required April 25.1997, the staff guidance was promulgation of new rules, plant-under S 50.59. The NRC neither published in the Federal Register as specific license amendments and other endorsed nor disapproved this draft NUREG-1606 (Proposed enalyses and reviews that may be document. While the staff concluded Regulatory Guidance Related to imp ementation of 10 CFR 50.59). for l conducted, such as in response to NRC that the evaluation process established bulletins and generic letters. The NRC in NSAC-125 was generally sound, the Public comment on May 7.1997 (62 FR prepares a safety evaluation for many of staff was unable to endorse the 24947). these issues based upon either licensee document because of some not ce any co r en we e sut tted requests for changes or licensee inconsistencies between the that voiced strong opposition to a responses to NRC requests for implementation guidance and the number of the positions proposed by the information. The licensee is required to lan e of S 50.59' staff. These comments were summarized periodically update the final safety On ctober 31. I997, the Nuclear analysis report to reflect effects of these Energy Institute (NEI) submitted for staff $t 8 a lo and Eva ua on of its changes so that the safety analysis review a revised guidance document, at d Septem\\er 1O report (as updated) remains a complete NEI 96-07, " Guidelines for 10 CFR 9 ce th rond accurate description and analysis of 50.59 Safety Evaluations." This time, the NRC has conducted a more i tne facility such that it can serve as the documetit, an updated version of detailed review of the comments and reference document for evaluation of NSAC-125 that NEl modified in concludes that some issues can be changes made under 10 CFR 50.59. response to some of the staff positions. resolved through guidance, while in 10 CFR 50.59 Evaluation Process and other implementation issues arising other areas, rulemaking is tiecessary to from licensee use of the NSAC-125 clarify the implementation issues. A Section 50.59 was promulgated in guidance. Along with the submittal of copy of this analysis of comments is 1962 to allow licensees to make certain the guidance document, NEl included available for review in the NRC Public changes that affect systems, structures, an industry-wide initiative that would Document Room. As noted. the staff l components, or procedures described in require industry adoption and concluded that rulemaking was the SAR without prior approval implementation of the revised guidance necessary to resolve some of the issues provided certain conditions were met. by June 1998. The NRC p vided associated with implementath.n of the In 1968, the rule was revised to modify comments to NL concerning this rule. some of the riteria for when approv ) guidance in a letter dated January 9. was requir The intent of the S 50. 1998. This letter noted that certain

11. Proposed Rule Topics and u o

i process is t ermit licensees to make as if this guidance were The NRC is proposing rulemak. r a changes tr : facility, provided the unacceptable for implementation of S 50.59 (and S 72.48) to address a chang utain the level of safety 5 50.59 as presently written. mimber ofissues concerning docun. .ed in the original licensing Staff efforts to develop guidance on

mplementation of the current ru e, and basis, such as in the safety analysis implementation of S 50.59 were suitability of the criteria that determine report. The process is thus structured prompted by a reassessment of the '^

when an unreviewed safety ques tion around the licensing approach of design CFR SC.59 evaluation process. exists. The implementation issu es basis events (anticipated operational conducted in 1995, that examined primarily relate to cases involving occurrenm and accidents); safety-existing guidance and practice, with the judgment as to whether a proposed related magation systems, and goal of identifying how the process change requires NRC approval before it consequence calculations for the design could be improved, or where additional can be imple:nented. The differing basis accidents. Margins and equipment guidance was needed. The staff interpretations of the rule as it relates to functionality, reliability and availability provided an action plan to the an increase in probability of an also may be impacted by facility Commission on April 15.1996, accident, or an increase in consequences changes. Therefore, the criteria for outlining the actions the staff proposed have contributed to disputed inspection rrquiring NRC approval were directly to complete with respect to guidance and enforcement findings. Too stringent related to: (1) Preserving licensing and oversight of implementation of an interpretation of the meaning of the assumptions concerning initiation of S 50.59. The staff review identified a requirements could result in diversion design basis events by not allowing a number of areas in which the meaning oflicensee and staff resources for review different type of initiating event or of the rule language is not clear, or of inconsequential changes. Too high a probability of occurrence larger than where staff and industry interpretations threshold for NRC review could lead to previously considered; (2) preserving (such as those in NSAC-125) are erosion of safety margins without NRC dfectiveness (reliability) of the different. In SECY-97-035, dated review, particularly from the cumulative mitigation systems by not allowing February 12,1997, the staff forwarded to effect of more than one change. In l introduction of different equipment the Commission proposed regulatory developing the proposed rule, the l malfunctions and by limiting increases guidance on implementation of 5 50.59. Commission has carefully weighed in probability of malfunction, or in this SECY. the staff presented these matters in trying to establish an reductions in the margin of safety positions on a number of topic areas. appropriate threshold for NRC review. (which reflects the capability of the These positions in some cases Conforming changes are proposed in system); and (3) preserving acceptability reaffirmed existing regulatory practice other portions of the rules, including of consequences by limiting increases in or clarified staff expectations, and in 5 50.66, 50.71(e) for production and consequences of the postulated design other areas, established positions where utilization facilities licensed under part basis events, guidance did not previously exist. In its

50. Conforming changes are also

l Fedrl Regist:r/Vol. 63. Nci. 203/ Wednesday. October 21,1998/ Proposed Rules 56101 required in S 72.212(b)(4) and (2) Form of prior Commission approval many facility technical specifications Appendices A and B to part 52 (Design Existing S 50.59(a) refers to the need refer to unreviewed safety question Certification Rules for ABWR and for prior Commission approval of determinations and such TS should { System 80+ respectively). changes, tests, and experiments under ultimately be revised in accordance In addition, the Commission is certain conditior's, but the method of with the final wording of S 50.59. The proposing to make parallel changes receiving that approval is not discussed deletion of reference to USQ also applicable to facilities for independent until paragraph (c), which states that the requires a number of conforming spent fuel storage facilities licensed in licensee shall submit an application for changes to other parts of the regulations. accordance with part 72. These changes amendment under S 50.90. The including Part 52 (Appendices A and B), are included in the sections below (in Commission proposes to combine these in which the term is presently used. some cases, the discussion of the issue two paragraphs and to revise the This proposed rule would revise the focuses on S 50.59 for simplicity; except regulation to state more clearly that a existing compound statements where noted. the discussion is also licensee must apply for and obtain a contained with the evaluation criteria to spplicable to the changes for S 72.48). license amendment. pursuant to S 50.90. state each specific criterion l As part of the proposed changes to part before implementing such changes, individually. This will rnake the 72, the Commission is also proposing to tests, or experiments. This regulation more consistet with how it extend the change control process organizational change to the rule of is generally implemented tiy licensees. authority granted to ISFSI or MRS combining (existing) paragraphs (a) and Changes to the criteria are discussed in the sections below. license holders (in S 72.48) to holders of (c) will also facilitate some of the other j NRC Certificates of Compliance (CoC) proposed changes, such as the criteria Finally, the Commission would J u 8 hen appmvalis needed.

[ g s at ent

• o de o n ad tion to anges to t e requirements within SS 50.59 and 72.48. (3) Criteria for needing Commission a license... who desires (1) a change the Commission is also proposing to approval of changes, tests and to its technical specifications... shall i

l rearrange certain provisions of these experiments and Unreviewed Safety submit an application for amendment of rules to provide a more logical structere. Ques. tion (USQ) designation his license pursuant to 5 50.90. This These changes do not affect the The Commission proposes to remove statement refers to changes to the TS not substance of the requirements, but the reference in the rule to the term asmc i rather affect only where they are located unreviewed safety question and e Peri n e Co sslor neludes l and how they are stated.These instead to refer to the need to obtain a that ore suita epa for t is organizational changes are discussed license amendment. The Conimission P I ther as par o th s ema g l first, followed by discussion of each of believes that the terminology of "USQ" the issues where revisions to has sometimes led to confusion about if a licensee wishes to amend its license l requirements are proposed by this the purpose of the evaluation required l rulemaking. The proposed rule revisions by 5 50.59. Some licensees have (including the TS incorporated into it). are presented in the order that the issues concluded that if they determined a the licensee must file an application as i currently arise in the regulations. change was safe, there could be no need specified in S 50.90. Revised S 50.59(c)(1) would be revised to state I' PP l A. Organization of the Rule Te o nrNs n notes that the that if a proposed change, test, or hquirements purpose of performing evaluations experiment would involve a TS change. The organizatforo % 'es being against the criteria specified in S 50.59 the S 50.90 process must be followed in p oposed include /. C ving: is to identify possible changes that rder to change the technical (1) Applicat411ty might affect the basis for licensing of the specification such that the proposed facility so that any changes that might change, test or experiment may be in the existing ru:e angttage pose a safety concern are either implemented. concerning applicab.ity to Cerent reviewed by the NRC or not B. Change to the facility as Described in facilities is contained in three differ ( ' implemented by the licensee. This the Safety Analysis Report paragraphs. These facilities are: evaluation process will thus distinguish Section 50.59 states that " changes to Production and utilization facilities those changes which by their nature do the facility as described in the safety (including power and non-power not raise safety concerns and therefore analysis report" must be evaluated to reactors) that are authorized to operate. do not require prior NRC approval to determine whether prior approval is and reactors (both power and non-confirm their safety, from those tha't needed before implementation. As power) that have permanently ceased must be reviewed by the NRC to discussed in NUREG-1606 and in the operations. The Commission proposes independently confirm their safety comment discussions, a common to place all of these provisions in one before implementation. To avoid understanding between the NRC and the paragraph that is clearly labeled confusion between a de'ermination of industry on what constitutes a " change " Applicability."2 safety and a determination of the need to the facility as described in the safety for NRC approval. the Commission analysis report"is necessary for 25ection 50.59(a) refers to holders of a license proposes to revise S 50.59 to delete use effective functioninE of the review authorizing operation of a productton or utilization f;cillry. Section 50.59(d) explicitly refers to power of the t&m "unreviewed safety process. Guidance on preparation of reactor licensees who have submitted certification question, and instead to list the criteria S 50.59 evaluations provides the means or permanent cessation of operauon required under (in new S 50.59(c)(2)) that require prior for review of the effects of changes, but 5 50 82(a)(1)(1). As noted in 5 50.82(a)(m). for power Commission approval,in the form cf a these reviews are not conducted if the pNs' ion operaI[cn. llCense amaridment, it is also noted that o e the e ect ve activity is not cons' *ered to be a date of this rule (that is of 5 50 82). the certification " change..." The Cominission of 5 50 82(a)(1)(1) shall be deemed to have been both power and nonpower reactors whether Concludes that modification of an submitted. Section 50.59(e) refers to non-power authorized to operate or no longer authorized to rractors whose license no longer authorizes OPerste (and to other production or utilizrtion existing provision (e.g., SSC, design operation. The ne* affect is that 5 50.59 applies to facilities). requirement, analysis method or

r 56102 Fedir:1 R: gist:r/Vol. 63, No. 203/ Wednesday, Octcber 21,1998/ Proposed Rules parameter), additions, and removals if changes to roethods and meet Appendix B (Quality Assurance), (physical removals or non-reliance on a assumptions were not controlleo, a and plans for coping with emergencies, system to meet a requirement) are all licensee might revise its analyses and per Appendix E. Section 50.59 applies changes to the facility as described in then subsequently conclude that a later to changcs to procedures as described in the final safety analysis. The facility change did not require NRC the SAR. Quality assurance and Commission believes that additions to approval taause the results of the emergency planning program the facility which were not previously (new) analysis with this change were requirements are subject to the change tvaluated, could adversely impact bounded by the previous analysis. This control provisions of 55 50.54(a) and facility performance and the bases upon proposed rulemaking would add 50.54(q) respectively Based on this set whici. the NRC previously determined definitions in 5 50.59 of " change" and of of rule provisions, it could be inferred the acceptability of the design as " facility as described in the final safety that changes to quality assurance or l described in the SAR. Accordingly, the analysis report (as updated)" to more emergency plans would require both a l Commission concludes that additions explicitly establish that evaluation is $ 50.59 evaluation and a S 50.54 leither should be considered " changes to the required for changes to the analyses and (a) or (q)] evaluation. The S 50.54 3 i facility as described in the SAR" In bases for the facility as well as for regulations provide criteria and order to assure that such changes are physical or hardware changes to the reporting requirements specific to the subject to evaluation using the S 50.59 facility. plans and which were promulgated after criteria for determining whether prior Accordingly, the Commission S 50.59. To reduce duplication of effort, i NRC review and approval are necessary. Proposes to add the following as the Commission proposes that changes definitions in section S 50.59; to these programs be governed by Differences in interpretation have Change means a modification, S 50.54 requirements, and that a S 50.59 occurred about whether changes that do l not actually change the physical plant ((g[a'373chdin the final evaluad n wm nt erq un as l al at n ea ple, consider a means () t e s u es,'s te and '*E l change being made to the basis components (SSC) that are described in Proposed rule would add language to l (documented in the SAR) for the final safety analysis repet (as specifically exclude from the scope of S 5159 changes to procedures where demonstrating adequacy of the facility updated), (11) design or performance ther more specific requirements and without a physical change to the requirements cr methods of operation i facility. Such enangts might include for such SSC required to be included er D l changes to evaluative methods, described in the final safety analysis I'E" * " " '

• E

' *"E** scceptance standards, procurement report (as updated), and (.'ti) evaluations S e" " m" "M a d H, h p a 8 "* " '*9 specifications, or other information for or methods of evaluation : equired to be Provision in the S 50.59(c)(1) of the SSC described in the FSAR. The included in the FSAR (as i pdated) for i l Commission believes that S 50.59 does such SSC that demonstrats that their Proposed rule. rpply to the requirements fcr design, intended functions will be The proposed definition for ., rocedures as described in the final construction and operation, and the accomplished or that their design bases P safety analysis repon (as updated) is as safety analyses for the facility that are can be met. f U ws: documented in the FSAR. Section The Commission endorses the staff's 50.34(b), " Final safety analysis report,** previously stated position (in draft Procedures as described in the /Inal safety requires the FSAR to contain a NUREG-1606) about what constitutes a analysis repon (as updated) means presentation of the design bases and the single change, as compared to packaging inf nnau n in h final safay analysis repon limits on its operation, a description of several changes with offsetting (as UP ated) regarding how systems, d and analysis of the SSC of the facility, effects. Interdependent changes (i.e., " "Yed Pe sum )operat con ol lud n with emphasis upon performance where a second change is caused by the actions and response times), including requirements, the bases, with technical first, with respect to function or assumed operator actions and response justifications therefore. :upon which performance), can be treated as a single times, and information on conduct of such requirements have been change, whereas treating as one change operations. established, and the evaluations the combination of changes (whether t D. Tests and Experiments Not Described rrquired to show that safety functions the facility directly or to the safety in the Safety Arialysis Report will be accomplished. The original analysis) to offset one that would licensing decision was based in part otherwise require prior approval is not Section 50.59 also discusses the upon the margins provided by an appropriate application of S 50.59. conduct of tests or experiments not performance requirements. analysis described in the safety analysis report. methods and assumptions described in C, Change to the Procedures as " Test" is, of course, subject to many the SAR, and reviewed by the staff in Described in the Safety Analysis Report meanings including both routine the SER. Therefore, the Commission The Commission proposes to provide verifications of function, and also more concludes that changes to such a definition of " procedures as described unusual evolutions. In the former information (e.g., performance in the safety analysis report" in order to category, there are many tests that are requirements, methods of operation, the have definitions in the rule for all the conducted that are not explicitly bases upon which the requirements major terms and criteria. This definition described in the SAR. For example, a have been established, and the would include the evaluations licensee conducts tests of component evaluations) should be considered to demonstrating that requirements are and system performance that verify the constitute a change to the " facility as met, such as assumed operator actions described in the SAR" in order to assure and response times. 3 Section 50.54(p) establishes change control that such changes are subject to The Commission also notes that requirements for sareguards conungency plans. evaluation using the S 50.59 criteria for S 50.34(b) states that the final SAR is to $'[,'o'pufsu$ niton 3 hWe$ pan or P determining whether prior NRC review contain the managerial and the FSAR. and thus 5 s0 59 would not apply so c.nd approval are necessary, administrative controls to be used to these plans.

Fzd;rtl Rigist:r/Vol. 63, No. 203/ Wednesday, October 21,1998/ Proposed Rules 56103 i SSCs perform the functions as described that evaluations need to account for would result in many changes requiring or required (ib.normance of tests is changes made through other processes prior NRC approval that are below the j a typicallv. niolled by procedure.) that have not yet been included in an level of significance warranting such Howo er, there also may be tests of new update to the FSAR. The Commission review. The position espoused in the materials nr means of plant operation did not use " Updated FSAR" for this revised Industry guidance document that may put the plant in a situation that purpose in order to take into account (NEl 96-07) is that an increase in i has not been previously evaluated and two special circumstances: (1) probability or consequences must be l that could affect the capability of SSC to Nonpower reactors, who are not discernable in order for approval to be perform their required functions. The required to submit updates to the FSAR, needed. The Commission concludes that existing rule was designed to ensure although they still need to consider the plain reading of the existing rule that the latter type of tests would be other changes previously made when language is not consistent with this reviewed before they were cor ducted. performing S 50.59 evaluations, and (2) Interpretation. Therefore, to assure that there is clear a plant licensed to operate, during the Although the current rule language definition with respect to the tests that period ber.veen initial licensing and the would not permit discernable increases are subject to prior NRC review and first update. This revision is reflected in in probability or consequences, the approval before they are conducted, the the definitions in the earlier sections Commission has concluded that at Commission proposes that a definition and in the following sections. The minimum, this would be a reasonable of " tests and experiments not described definition also refers to " Final Hazar.is standard for requiring prior approval of in the safety analysis report" be Summary Report " which is the changes tests or experiment for provided in 5 50.59 as follows: applicable document for some er ly increases in probability of occurrence of P ants whose application was r.bmitted an accident or malfunction. The existing l Tests or experiments not described in the finalsafety analysis report (as updated) before the regulatory term "sr'.ety rule language dates from early in the means any activity where the reactor or any analysis report" was adoptea. development of reactor regulation, of its systems, structures, or components are The proposed definition.s as follows: where with the knowledge base at the l Final safety analysis repor. (as updated) time, the then-AEC found it appropriate used or controlled in a manner which cannot i be shown to be within (1) the controlling means the final safety anal' 61s report (or to set a very low threshold for changes. parameters of their design bases as described Final Hazards Summary Peport) submitted in Over the last thirty years, the j in *he final safety analysis report (as updated) accordance with 5 50.34 as amended and Commission has garnered experience '11) consistent with the analyses in the supplemented, and as modified as a result of with implementation of S 50.59 and fmal safety analysis report (as updated)- changes made pursur at to 550 59 and insights from probabilistic risk E. Safety Analysis Report 5 50.90, and, as apphcable 5 50.71 (e) and (f). assessments, both of which indicate that in developing the proposed rule F Preabry or Occurrence or this threshold can be adjusted without changes, the Commission noted the Consegoences ofan Accident or adversely impacting safety. Further, the varying references to the safety analysis Afalfursction of Equipment Important to analytical capabilities to calculate report within related sections of part 50. Safety Previously Evaluated in the ,P obabilit s h ve greatly advanced, For example, in S 50.59, the phrase used Safety Analysis Report may be is " safety analysis report," in S 50.66, Increased g evaluated. Therefore, the Commission the reference is to the " updated final The current language of the rule states proposes to revise existing paragraph safety analysis report:" and S 50.71(e) that an unreviewed safety question 5 50.59(a)(2)(1) of the rule by replacing refers to the updated FSAR. (Other exists when the probability of "may be increased" with "would result sections and parts generally refer to the occurrence or consequences of an in more than a minimal increase," in final safety analysis report (e.g. part 55), accident or malfunction of equipnient order to provide that there must be a but this is not universally true (e g. important to safety previously evaluated clearly discernable change to require 5 50.54(a)), For purposes of S 50.59, may be increased (emphasis added). approval, the " minimal increase" " safety analysis report" refers to the Many of the concerns with current concept is described in the next section. current revision of the FSAR, so that the implementation relate to the appropriate As noted above, the ia)(2) paragraph changes are evaluated against the most interpretation of the words " probability would be broken into four statements complete and accurate description of of occurrence.. or consequences... and renumber 2d as (c)(2)(1) through (iv). the facility. When performing may be increased." In the draft NUREG-evaluations, a licensee needs to consider 1606, the NRC staff stated that the plaln C Af re thana Afinimallncreasein changes already made for which the reading of the words would mean that Probability or Consequences FSAR update has not yet been uncertainty about whether there has The Commission notes that S 50.59 submitted to the NRC. The Commission been r t crease must lead to the permits changes that do not otherwise emphasizes the need for as current a cwre.a that the criterion is met. As require approval (such as would be the l reference base as possible for 5 50.59 au lt of trying to deal with the case if the provisions being changed are l evaluations, in order that the qt. a on o? uncertainty, licensees were in TS or license, quality assurance or evaluations appropriately consider other placeu m the position of having to prove emergency plans, or inservice changes already made that may have there could not be an increase, even inspection and testing programs). impacted the facility or procedures. when there was no reason to believe Because the information being revised is j However, a licensee is not required to that the proposed change, test or of less immediate importance to public submit an update to its FSAR in the experiment would have that effect. A health and safety, and in considention form specified by 5 50.7)(e) except at similar problem was experienced in of the conservatisms in NRC design and the required frequency. To enhance considering whether the possibility of analysis requirements, acceptance consistency, the Commission is an accident or malfunction of a different criteria, and the precision with which proposing to revise the rule language in type may be created. safety analyses are performed, these sections to add a definition of the Many of the commenters on the staffs " minimal" variations in probability of final safety analysis report (as updated) proposed positions viewed this as occurrence or consequences of accidents and to clarify in the evaluation criteria overly restrictive and stated that it and malfunctions should n3t affect the (

q b 56104 Federtl R: gist:r/Vol 63, No. 203/Wedn:sday, October 21,1998/ Proposed Rules 1 p b sis for the licensing decision. This required except for those instances in malfunction probability rather than as conclusion is based upon the qualitative which a licensee offers other than " accident probability." consideration of probability during qualitative arguments as part of its Consequences o/ Accident or l plint licensing; accident probabilities evaluation. Afalfunction i w re assessed in relative frequencies; I equipment failures were generally Probabdity ofOccurrence ofan u ance n - s ates..Mem j Accident postulated to gauge the robustness of the a change in consequences is so small or d; sign, without estimating their The current guidance in NEI 96-07 the uncertainties in determining l likelihood of occurrence. Therefore, states: "Where a change in probability is whether a change in consequences has j minimal increases in probability could so small or the uncertainties in occurred are such that it cannot be I not even have been identifiable, and determining whether a change in reasonably concluded that the could not impact the conclusions probability has occurred are such that it consequences have actually changed reached about acceptability of the cannot be reasonably concluded that the (i.e. there is no clear trend towards facility design. Radiological probability has actually changed (i.e. increasing the consequences), the consequences for accidents are there is no clear trend towards change need not be considered an calculated and reported at a level of increasing the probability), the change increase in consequences." The NRC precision such that minimal increases need not be considered an increase in believes this satisfies the revised NRC also would not impact the safety probability." The Commission believes standard. ditermination. The Commission this satisfies the proposed NRC If a licensee has performed an therefore concludes that the proposed standard. analysis with certain bounding criteria would provide reasonable In order to be considered as a minimal assumptions, and the change would cssurance that those changes that would increase, the resulting probability increase a specific parameter from its aff:ct the NRC's basis for licensing (considering the change, test or present value to a different value that is would be identified as requiring NRC experiment) must still satisfy the event still bounded by the value assumed in approval before implementation. The frequency classification provided in the the analysis, NRC concludes that such a rrvised criteria would also provide licensee's FSAR (as updated), e.g., for an change satisfies the criteria of no more some degree of flexibility for licensees anticipated operational occurrence than a minimalincrease in j to make changes with smaller impacts (expected once a year) or for a design consequences. without the need to obtain a license basis accident (not expected during life As a quantitative measure, the I amindment. of plant, but sufficiently credible to Commission is considering some i On the other hand, the Commission rLquire raitigation). options. One would be to establish that int:nds to limit the amount of increase a 0.5 rem increase in calculated dose as ProbabuRy ofEquipment Malfunction in probability or consequences of a result of the change be used to assess i accidents such that it remains The Commission believes that the whether a minimal increase has substantially less than a "significant Probability of malfunction is more than occurred. This range of change would increase" as referred to in S 50.92 (in minimally increased if a new failure generally be in the decimal place for accordance with 5 50.92, a license mode as likely as existing modes is accident analyses where doses are amendment involving a significant introduced. The determination should reported in rem. The facility must still increase in the probability or be made either at the component level, satisfy applicable acceptance values consequences of an accident previously or consistent with the failure modes and (e.g., the SRP) or regulatory evcluated involves a "significant effects analyses, taking into account requirements (e g., part 100) for the hazards considerations;" any hearing for single failure assumptions, and the level particular accident. If a licensee would j an amendment constituting a of the change being rnade. need to change its design basis l "significant hazards consideration" Guidance in NEl 96-07 states: "Where assumptions or analytical methods, or must be completed prior to the grant of a change in probability is so small or the both, to demonstrate that the change in the amendment.) The standard in the uncertaintit s in determining whether a consequences is less than 0.5 rem, then proposed rule is qualitative (probability change in probability has occurred are the NRC does not view the change as ) or consequences no more than such that it cannot be reasonably minimal and would expect the licensee i minimally increased). The intent of this concluded that the probability has to submit a license amendment for such j proposed rule is to allow changes that actually changed (i.e. there is no clear a change. tre small enough that they wruld not trend towards increasing the in addition, the Commission is affect the facility's licensing basis, or probability), the change need not be considering a graduated approach, tdversely affect safety performance, considered an increase in probability." consistent with the concept of While the proposed rule would allow The Commission believes this satisfies " minimal" being small enough so as not i minimal increases, licensee still must this criterion. to impact the basis for acceptability. meet applicable regulatory limits and The probability of malfunction of When the facility is far from the limit, I other acceptance criteria to which they equipment important to safety a larger increase can be accommodated are committed (such as contained in previously evaluated in the FSAR (as without concem about impact on the Regulatory Guides, etc.) Because the updated) is no more than minimally basis for acceptability. The values "more than minimal" standard allows increased if " design bases" assumptions proposed take into account such factors for there to be a discernable increase, and requirements are still satisfied (i.e., as differences between licensee NRC needs to establish a point beyond the seismic or wind loadings, calculated values and staff estimation of which one would conclude that the qualification specifications, existing performance, potential for a increase is not minimal. The following procurement requirements). As part of single change with a large increase, or guidance is offered including values as this guidance, note that NRC concludes for several " mint '" increases to to when the Commission would that licensees can treat changes in approach the remsatory limits. The conclude that the revised criteria are not external hazard design requirements as specific proposal offered for comment j met. Quantitative calculations are not potentially affecting equipment is: l l j

Federd Regist:.r/Vol. 63, No. 203/Wedntsday, October 21,1998/ Proposed Rules 56105 { l Example using 300 rem thyroid dose as the limit. Existing calculated dose " Minimal" change Pre-change $8' 'h ,ng <50% of limit 510% increase 140 rem 170 rem. 580% of limit 55% increase 205 rem - 220 rem. wre than 80% - 51% increase (NTE limit) ,245 rem 248 rem. A third option under consideration, discussed below in this section and the from operation of the facility and similar to option 2, would limit the following one. As noted earlier, the including determination of (1) the fraction of remaining margin that can be Commission is proposing to separate the margin-Sty during normal consumed by a particular change. By requirements into distinct criteria for operar J transient conditions defining " minimal" as being 10% of the clarity. This criterion would now read ant %c ring the life of the facility remaining margin between current "if a possibility for an accident of a anc' .t% quacy of SSC provided conditions and acceptance guidelines, diffe ent type from any previously for t, 'on of accidents and the the amount of change would decrease as evaluated in the final safety analysis mitigation of a consequences of j the limit is approached, and the limit report (as updated) is created." Under accidents." R, i.70 states that the FSAR could not be exceeded. the proposed rule, a license amendment is to include postulated anticipated would be needed only if the licensee operational occunences; postulated off-CumulaWe Mect reasonably concluded that the design transients that induce fuel The Commission is concerned about possibility of an accident of a different failures above tho:;e expected for normal the cumulative effect of minimal type is created. This contrasts with the operational experience, and design basis increases. Since some increases are current rule, which would require a accidents. The Standard Review Plan for s.llowed, the Commission believes that license amendment if the licensee is Chapter 15, refers to anticipated the proposed process would placa uncertain or unable to reasonably operational occurrences and to greater importance c..: (1) Complete and conclude that a new accident of a postulated accidents, and also to accurate SAR updating; (2) the different type is not created. The " transients and accidents" (the SRP licensee's evaluation process taking into Commission concludes that this notes that other events, such as response account other changes made since last proposed rule change will still identify to external phenomena, are covered in update; (3) the licensee's screening those proposed changes tests, or other chapters). process examining plant changes to experiments that the NRC should Design basis accident (s) has been used determine whether they are indeed review, without also including other in regulatory practice both singularly changes requiring evaluation; and (4) changes of lesser significance that may and generally. The regulations also reporting requirements so that staff can be viewed as meeting the existing include the concept of a design basis assess the ongoing nature of cumulative criteria. accident (DBA). for purposes of e lssue then becomes how the NRC Need for Definition ofAccident evaluating siting, which is an assumed can best oversee the process such that In determining whether a proposed fission product release, based upon a major accident that would result in several " minimal" changes do not result change requires prior NRC approvil potential hazards not exceeded by those in unacceptable results. The under S 50.,59, the rule refers to whether from any accident considered credible. Commission has decided to require accidents previously evaluated in the licensees to report effects of changes in SAR are impacted, or whether an Such accidents have generally been assumed to result in substantial a different manner to ladlitate accident of a different type may be.. meltdown of the core with subsequent evaluation of cumulative effect, as created (see also S 50.92 criteria.or, n release of appreciable quantitles of discussed in a later section on repor.ing significant hazards consideration). requirements, in which the Commis sion Those accidents evaluated in the SAR, fission products The set of" accidents" proposes to require that the SAR update that is, those events that a plant must that a plant must postulate for purpo.;es of FSAR design and safety analyses, in accordance with S 50.71(e) discess show that it can withstand, are derived including LOCA. other pipe ruptures, the effects of the changes upon from a number of regulatory rod ejection, etc., are often referred to as calculated doses and other informathn. requirements, and the safety analyses are included in the FSAR. " design basis accidents". H. Posslbility of an Accident of a The regulations and NRC guidance The terms of accidents and transients Dl/Terent Type from anyPredously documents, refer to "a design basis are often used in regulatory documents Evaluatedin the Safety Analysis Report accident" (5 50.30), to design basis (as for example in Chapter 15 of the may be Created events (S 50.49), to loss-of-coolant Standard Review Plan), where transients As noted in Section F above, the accidents (Appendix A), to anticipated are viewed as the more likely. Iow uncertainty connected with operational occurrences (Appendix A) consequence events and accidents as demonstrating that no accident or and to accidents that could result in more serious. In the context of malfunction may have been created is a release of significant quantities of Probabilistic risk assessment, transients major source of confusion and difficulty radioactive fission products (part 100). are typically viewed as initiating events, in implementing the existing rule; rW The PSAR, and by extension the FSAR, and accidents as the sequences that is unnecessary for purposes of pursuant to S 50 34,is to contain result from various combinations of P ant and safety system response. l identifying when NRC review of a " analysis and evaluation of the design change is needed. Accordingly, the and performance of SSC of the facility However, the meaning of the term Commission proposes that the language with the objective of assessing the risk " accident" as it is used more generally in existing S 50.59(a)(2)(II) be revised as to public health and safety resulting in Part 50, is somewhat obscured by the

l 56106 Fed:rtl Regist:r/Vol. 63, No. 203/ Wednesday, October 21,1998/ Proposed Rules use of the term " design basis event." In require a determination that the in implementing this position. S 50.49, design basis event is defined as: possibility has been created. rather than attention must be given to whether the normal operations including anticipated uncertainty as to exclusion. malfunction is evaluated at the operational occurrences. design basis The second change is to insert the component level or the overall system accidents, extemal events, natural words "of equipment important to level. While the evaluation should take phenomena (earthquakes, tornados. safety." The existing rule does not into account the level that was hurricanes, floods, tsunami and seiches), for provide this characterization within previously evaluated in terms of which the plant must be designed to ensure paragraph (ii), but it is included in malfunctions and resulting event salety-related functions. paragraph (1). It has generally been initiators or mitigation impacts, it also in view of the range oflanguage inferred that the statement in paragraph needs to consider the nature of the presently used to describe the types of (11) is an abbreviated version of that in change. Thus for instance, if failures events evaluated as part of the licensing paragraph (1). A review of the history of were previously postulated on a train basis, the Commission is contemplating the 1968 rulemaking adopting revisions level because the trains were the need to clarify its intent as to the to S 50.59 did not disclose any independent. a change that introduces a extent of events that are within the discussion suggesting that the cross-tie might need to be evaluated to purwew of the criteria in S 50.59 and in Commission intended to distinguish see whether new outcomes have been S 72.48). For purposes of stimulating between the (a)(2)(i) and the (a)(2)(ii) introduced. The staff has provided discussion. the Ccemmission offers two criteria with respect to the scope of guidance on this issue in Generic Letter proposals. One would be to set forth a equipment covered. Therefore, the (GL) 95-02, concerning replacement of definition 5 the term " accident" as Commission concludes that the rule was analog systems with digital follows: intended to apply to the same scope of instrumentation. The GL states that in e9ui ment in each cases, and therefore. considering whether new types of P en inittaung event or combination of events and/or conditions that could occur from Pmposes to include the words in this failures are created, this must be done equipment failure, human error, natural or criterion to elimMate any doubt. at the level of equipment being manmade hazards which challenges the The final chang is bcing proposed in replaced-not at the overall system integrity of one or more fission product response to the comments on the staff-level. Further, it is not sufficient for a barriers (fuel, reactor coolant system. release proposed guidance (NUREG-1606) on licensee to state that since failure of a l of radionuclides (confinement / containment)), the interpretation of malfunction (of system or train was postulated in the required to be analyzed and/or accounted for equipment important to safety) of a SAR, any other equipment failure is by the Commission and addressed in the different type. The commenters believe bounded by this assumption, unless licensee s safety analysis report. that the cause of the malfunction should there is some assurance that the n. ode Such a definition would make it clear be a consideration in determining of failure can be detected and that there that the Commission's Mtent in referring whether the probability of the are no consequential effects (electrical to " accidents" in S 50.M (and in malfunction may have increased, and interference, materials interactions, etc), S 72.48) is to refer to the design basis that a malfunction of a different type such that it can be reasonably accidents that are addressed in the SAR. would only be created if the effects of concluded that the SAR analysis was The second approach is to add the the malfunction are not already truly bounding and applicable. phrase " design basis accident" into the bounded by the FSAR analysis. The Otherwise, the Commission would existing criteria. This could be done for recent industry guidance states that if a conclude that there was increase in each of the three criteria that refer to component were subject to failure from probability of malfunction or that a " accident" orjust for the one on a new failure mode but the failure of the malfunction with a different result has accident of a different type. Since the component is already considered in the been created. criteria on probability and consequences safety analysis, then there would not be also contain language about "previously a failure of a different type.The / Margin ofSafety as Definedin the evaluated in the SAR " there may be Commission does not agree that the Basis for any Technica1 Specification is Reduced less need for a reference to " design basis industry interpretation is consistent accident" in these criteria. The with the rule as written, which refers to Two criteria in the current regulations proposed rule language includes use of creation or possibihty of a malfunction (S 50.59) specifically focus upon the phrase " design basis accident" in of a different type, not of a different axidents and equipment malfunction the one criterion, for purposes of result. However, the Commission (creation, consequences and likelihood) obtaining public comment, recognizes that in its reviews, as the measures for determining when a

1. Possibillry of a Malfunction of a equipment malfunctions are generally change requires prior NRC approval.

postulated as potential single failures to However, the phrases " margin of safety" Different Type from any Previously evaluate plant performance; thus, the and "as defined in the basis for any Evaluated in the Safety Analysis Report focus of the NRC review was on the technical specification" in the third may be Created result, rather than the cause/ type of criterion have been the subject of In a similar fashion, the Commission malfunction. Unless the equipment differing interpretations because the proposes to modify the remaining part would fallin a way not already rule does not define what constitutes a of existing S 50.59(a)(2)(ii), concerning evaluated in the safety analysis, there is margin of safety or a basis for any malfunctions of a different type by no need fer NRC review of the change technical specification in the context of creating a new criterion that would read that led to the new type of malfunction. SS 50.59 and 72.48. In addition, some "if a possibility for a malfunction of Therefore, as the third change in have questioned the need for the third equipment important to safety with a S 50.59(a)(2)(ii), the Commission is criterion on " margin of safety / different result than any evaluated pmposing to change the phrase "of a The Commission has under previously in the final safety anclysis different type" to "with a different consideration a number of proposals on report (as updated) is created." This wsult". Therefore, this criterion would margin. In the pioposed rule text criterion involves three revisions to tL "if a possibility for a malfunction specifically being offered for comment, existing rule. The first change is the uss wipment important to safety with a one option has been inserted so that of the phrase "is created" which would at result.. is created." commenters can examine the m.

Federal Regist:r/Vol. 63. No. 203/Wednisday, October 21,1998/ Proposed Rules 56107 relationship of this aspect of the licensee operations. Therefore, for this requirement, are altered in a nonconservative proposed rule to other changes being proposed rulemaking, the Commission manner. 1 offered. This should not be viewed as is offering the public the opportunity to Although this option would maintain meaning that this option is preferred by comment on a range of options for the safety analyses that underlie the TS, the Commission. The range of options treating margin. Commenters are this approach would also have the effect under consideration is discussed in requested to present opinions about the of giving input values and assumptions more detail below, merits, or concerns about the specific the weight of TS, which is inconsistent Questions of margin are commonly proposals, or both, and also to offer any with the philosophy in S 50.36 of judged in terms of the degree of other suggestions for wording. establishing TS only on those values of confidence that the response of the facility, or of particular SSC, to Option 1: Controllnputs to Analyses most immediate safety importance. In postulated challenges is acceptable. and Methods that Establish TS many instances, changes to inputs can be accommodated by othe available Various margins exist in a facility The Commission believes it is margins so that the licensing envelope design. These margins are based on, for reasonable to interpret the specific is preserved. I example, assumptions of initial reference to " basis for any technical conditions, conservatisms in computer specification" in the 1968 rulemaking Opthn 2: Delete " margin ofsafety" as I a Criterion. modeling and codes. allowance for that added the " margin of safety" Instrument drift and system response criterion as preserving the margins in Under this option, the Commission time, redundancy and independence of the analyses that established the TS would delete any criterion focusing components in safety trains, and plant requirements. For instance, the upon margins. Instead, the Commission response during operating transient and minimum plant performance conditions would rely upon the other criteria in recident conditions. Margin to and configurations stated in the TS are S 50.59, as well as the regulatory conditions that might be detrimental to the limiting conditions for operation, requirement that all changes to TS be i safety is also determined by establishing limiting safety system settings, and reviewed and approved by the NRC to acceptance criteria to be met for safety limits. Margins of safety exist assure that there are no significant response to various accidents and within the safety analyses as a result of adverse changes to margins in design transients. Acceptance criteria are the specific input assumptions, and operation. The Commission would established at a value that accounts for methods, or other limits that were used. argue that there is no need for prior uncertainty about physical properties These parameters and methods were review of changes that do not satisfy any and other variability and thus provides proposed by the licensee and reviewed of the other evaluation criteria in view margin to unacceptable plant by NRC to account for uncertainties, of " risk-informed" insights and greater conditions. Margins are built into the instrumentation response, and ranges of understanding of the margins that exist frcility to account for routine plant possible operating conditions. Because through meeting the body of regulatory fluctuations and transients. Margins are S 50.59 requires prior NRC approval for requirements. The Commission seeks i also built into the plant to establish the a change to the TS, a change that could comment on whether any of the other tegulatory envelope within which a invalidate the basis upon which the TS evaluation criteria should be revised plant has demonstrated its ability to values were established should also were this approach to be adopted. respond to a spectrum of design basis receive prior approval. In accordance Option 3: Control margins associated accidents. it is in this category terned with this interpretatPys changes that with results of analyses the " regulatory envelope,' that the NRC invalidate these specc. :onditions believes that regulatory oversight of described in the FSAR & analyses that Inste d of focusing on the inputs to changes in margin may be needed from established the TS requirement (such as safety analyses, another interpretation w uld be to examine the results of the the standpoint of S 50.59. Thus the a limiting condition of operation. or a Commission notes that not all margins limiting safety system setting) would safety analyses, and to determine fall within the pmview in which reduce the margin of safety associated whether changes to operatioaal characteristics or other information changes to the margin require prior NRC with the TS' option, the Commission described in the FSAR (as updated) approval. As part of this rulemaking, the Under this Commission wants to clarify which would conclude that the analyses and w uld reduce the level of protection margins fall within the regulatory information in the FSAR establish the afforded by the TS (i.e., by the limiting envelope and how possible reductions basis for the margins of safety for the safety system settings and limiting in margin resulting from facility or TS. Thus, the Commission would c nditions of operation), as reflected in the re s f saf a ses procedure changes, or from conduct of propose to add a definition for tests and experiments should be " reduction in margin of safety evaluated. associated with any technical facili;y, the NRC established a level of In defining in the rule a standard for specification" and to conform the required performance (which will be referred to in this discussion as NRC revjew and approval of changes to criterion for needing a license margins in the regulatory envelope, the amendment in new S 50.59(c)(2). The acceptance criteria) for certain physical Parameters, such as those that define the Commission may want to preserve the existing terminology of " basis for any integrity f the fission product barriers NRC's ability to review changes when TS" would be,, replaced by " associated there is a potentially significant with an TS (fuel cladding, reactor coolant system j reduction in a margin of safety,* but The f Ilowing definition would be boundary and containment). Satisfying clearly would not want to unduly affect added: these acceptance criteria (or regulatory limits) produces a margin of safety to Reduction in margin otsafety associated loss of barrier integrity. The safety a end rfe$tsi Ia (("P([3$##hI analyses presented in the FSAR (as o gnn ni d ci a P n a yt ca margin of safety do not rneet the criteria for a *'no updated) demonstrate that the response tj of the barriers to the pcstulated P c5'a"na En"gYsigIincant re i lo 1 the a e y analy sp f na a margin of safety are not to be performed under safety analysis report (as updated), that accidents, transients, and malfunctior's 10 CFR 50.59. established any technical specification meets the acceptance criteria. For

56108 Fed;r:1 Registir/Vol. 63. No. 203/ Wednesday, October 21,1998/ Proposed Rules certain of these parameters TS safety operations) and the associated for any TS can be reasonably viewed as limits have been established; these regulatory limits is a possible that margin associated with preserving safety limits are limits upon important interpretation as to "the margin of safety integrity of these barriers. Therefore, the process variables that are found as defined in the basis for any TS". NRC is also considering a more explicit necessary to reasonably protect the which would be subject to the 10 CFR linkage to the response of the three integrity of physical barriers that guard 50.59 evaluation process. Thus, one fission product barriers generally relied against the uncontrolled release of proposal under consideration would be upon to provide protection from radioactivity. to define " margin of safety" as follows: uncontrolled release of radioactive However, for other parameters, a The " margin of safety as defined in any materials from a reactor facility Under licensee must determine the licensing technical specification" (margin of safety) is such a proposal, the text of the rule basis of the parameter in question by the amount (quantitative or qualitative) of would explicitly state that it is the reviewing the plant-specific safety margin between the operation of the facility response of fission product barriers analyses. The acceptance criterion is as described in the technical specifications (fuel, reactor coolant system, and that value approved by the NRC for a knd the exceedance of safety limits listed in containment) to accidents, translents, particular parameter or process variable the technical specifications or other (e g., ASME Code stress limits, a regulatory limits. In relaticn to accident and malfunctions that is being controlled departure from nucleate boiling ratio N'IenEe tb8 "calculab The following could be given as a h t rs limit or rnaximum critical power ratio (e.g., peak fuel clad temperature, maximum definition of margin of safety and of limit or containment design pressure). RCS pressure, etc.) and the associated fission product barrier response. These acceptance criteria may be stated regulatory or safety limit. The margin of Regulatory guidance would explicitly in the FSAR, may be in NRC safety is a product of specific values and list the parameters (for PWRs and regulations, or may be presented in the limits contained in the technical BWRs) that are to be controlled. NRC Standard Review Plan. (Note: This Specifications (which cannot be changed approach may require some licensees t without NRC approval) and other values' The margin of safety for any fission such as assumed accident or transient initial Product barrier response is the difference revise their FSAR to accurately describe conditions or assumed safety system between the calculated value and its the regulatory values for the set of response times, which are not specifically associated acceptance criteria. Fission critical parameters. For example, contained in the technical specifications. Product barrier response means those licensees would need to identify the Any change to the values not specifically Parameters that must be satisfied in the event of ostulated design basis events to expected operating or design values and containcd in the technical sp *1 cations P then specify the minimum performance must be evaluated for impact on the margin demonstrate integrity of the fuel, reactor between the calculated result of an accident coolant system and containment system capabilities for the related parameters, which cannot be modified with NRC r transient and the Safety r regulatory limit. barriers, review). With this option, before changing The following parameters would be in constructing the requirements for operational che acteristics described in included: Fuel and cladding controlling margin through the UFSAR (not directly controlled by performance (peak cladding consideration of results of analyses, TS), a safety evaluation must be temperature, or energy deposition, there are three aspects to take into Performed to determine, among other DNBR or MCPR, oxidation), RCS account: (a) Which results/ parameters things, if the change results in a performance (pressure, flows, stress), tre to be controlled through the 5 50.59 reduction in the level of protection and containment performance (peak process, (b) the degree of change to be afforded by the TS (margin of safety as pressure, containment leakage). Ellowed without review, and (c) how the defined in any TS). Such a reduction OPTION 3(A)(3)-Specilled Parameters changes should be evaluated in would typically occur only if the demonstrating that the criterion is operational characteristic had been used A variant on the previous option as a bounding condition in the analysis would be to actually list the parameters satisfied' sections below, these three upon which the selection of TS was of interest directly in the criterion for in the aspects are separately discussed in order based, or in analysis where the Prior review, as for instance, the to amplify upon the issues under acceptability of selected TS values was criterion could read: consideration. However, any rule demonstrated. Licensees could make (vil) Result in a change to the FSAR (as language option would need to include desired changes tv operational updated) calculated value of RCS peak some provision for each of the three characteristics without prior NRC Pressure, containment peak pressure, or fuel e approval, provided that the change does Performance (DNBR/MCPR, others), etc. asp (a) cts.Which parameters should be not result in accident analysis results This variant has the advantage of controlled? that are nearer the regulatory, or safety, being more precise, but the rule The margins of safety that would be limits than the corresponding results language would need to be crafted to controlled by the 10 CFR 50.59 process that the NRC used in evaluating the account for various reactor types. can be characterized in different ways. eptabill of the TS during licensing OPTION 3(A)(4)-Include Mitigation OPTION 3(A)(1)-Safety and Regula tory Y Capability Limits OPTION 3(A)(2)-Fission product The Commission is interested in barriers-definition The margin between regulatory limits preserving the integrity of both and the failure of physical barriers is The NRC notes that S 50.36 prevention and mitigation capabilities protected in the regulations (and also in (requirements for Technical available in the plant. and is therefore the portion of the Technical Specifications) has criteria for when TS considering an option that would l Specifications (TSs) called " safety are to be provided that specifically are include both features within the i limits"). The margin, as reflected in tied to design basis accident or transient " margin" criterion if the margin approved safety and accident analyses, analysis that either assumes the failure criterion is maintained. If this approach between the protection afforded by the of or presents a challenge to the were adopted, the definition or the list TSs (e.g., the limiting safety system integrity of a fission product barrier. of parameters would be supplemented settings and limiting conditions of Thus, the margin as defined in the basis with the performance parameters for the

I Feder:1 Registtr/Vol. 63, No. 203/ Wednesday, October 21,1998/ Proposed Rules 56109 accident mitigation capability of the OPTION 3(B)(2)-Minimal Amount-guidance, to which the licensee is committed I plant,asforinstance ECCS Definition ofMargin Reduction through its FSAR (as updated), as the basis performance (pressures, flows, actuation As discussed in other sections of this .ccie,'$$*[ent Nunct[o" P "" I ' ** values), engineered safety feature notice, the Commission concludes that performance (flows, pressures, spray the revised rule should allow licensees (c) Evaluation of effect of the change effectiveness, system efficiencies). some flexibility in making changes, up n ssion al'so notes that the he r Finally,in conjunction with any of through development of a minimal these approaches, the Commission is increase" standard. In considering results of safety analyses are subject to slso considering whether there are other margins, the Commission is thus variance depending upon the parameters important to preservation of weighing how such a concept could be assumptions, analysis methods or barriers that should be explicitly applied. One option would be that NRC analytical techniques used. In many instances, these factors were reviewed defined. For instance, for fuel stored in approval would be required for a i spent fuel pools, or for the reactor change, test, or experiment if the output by the NRC during its licensing deliberations, and their use may have a during periods of shutdown or f rmed part of the basis for the ,jtered b or t in a amount. refueling, there may be other analysis results (water level, pool temperature) The " marg! )" criterion would be e nelusi n that acceptable safety l In lieu of reactor coolant system modified to state that a change in margins were demonstrated. Therefore. calculated result of "more than a the Commission wishes to ensure that pressure. Therefore, the Commission seeks input as to whether there are other minimal amount" would require prior proposed changes by a licensee would review and approval. Either in the rule n t invalidate these conclusions by i parameters of interest beyond those itself, or in guidance, the Commission requiring a demonstration that the previously offered that should be would define " minimal amount", eva au n n ques and analyses are sdtaNe. included within the " margin of safety" modeled upon the options offered for To accomp}i h this, the Commission l criterion if that criterion is maintained, minimal increases in consequences (see and how should the rule language be section II.G. of this notice). For example, gehever defin tion of rgin of revised to specify what those parameters there could be a fixed amount (percent safety reduction" is selected the might be, change) in margin, as long as regulatory following statement (Option 3(c)b (b) Determination of reduction in limits are still met, if guidance itemizes mar in re utring review the parameters, such guidance could All analyses and evaluations for assessing the impacts f NPosed changes must be P also customize how " minimal" should Once the parameters of interest are performed using methodology and analytical i dged for each particular parameter techniques which are either reviewed and determined,it is also necessary to (allowing greater amounts for certain approved by the NRC or which are shown to define when a reduction in margin parameters depending on precistor) of meet applicable review guidance and warranting NRC review and approval calculations, sensitivity of results and standards for such analyses. l has occurred. The Commission is other considerations). The alternative to this proposed evaluating options ranging from any For instance, the definition of noncon language would be to rely upon a values,, servative change in calculated" margin of safety reduction * * *" licensee's design control procer.ses to a minimal change, might be stated as followr standard, and ultimately an option that under their quality assurance Reduction in margin otsdery tneans that requirements and program, to provide would allow increases up to specified as a result of a change, the [MARGINIis the assurance that any evaluative work limits (acceptance criteria), for those altered in a nonconservative manner by more has been conducted with methods and parameters that may be established in than a minimal amount. the regulations or NRC guidance (such techniques comrnensurate with the OPTION 3(B).(3)-Afinimal Determined safety significance of the analyses being approaches to the limits might be With Respect to Acceptance Criteria performed. controlled in a graduated fashion as was Mvallable Afargin) i discussed in the section of this notice Impacts for Pan 72 Changes relating to " minimal increases"). An It is also possible to achieve this Certain of the options discussed above option for the degree of reduction would by mo i ng ag may need t be modified for application be paired with an option (such as one 8 B Y,nd to TS)' ,, n 1h to independent spent fuel storage of those listed in (a) above) to provide "[,,*[t facilities or spent fuel storage cask te i 9 the text of the rule, es gnsin an e theraH for barrier response, with respect t9 l OPTION 3(F)(1)-No Reduction meeting the acceptance criteria for those philosophy would be the same, the barriers. For example, rule language particular outputs or barriers that would j One approach would be require that could read as follows: be specified for reductions in margin would have to be defined in terms of the the safety analysis, considering the License amendment needed if as a [ effect of the change, must show that the result of a change, test or experiment: barriers against release of radioactivity afforded by fuel storage facilities. For accident analysis results are not nearer (v11) there is more than a 10% reduction in instance, these might include calculated to any safety or regulatory limit, thus, a the difference between the calculated value fuel temperature or cladding oxidation. "no reduction in margin" standard. and the acceptance criteria for fission Possible rule text: Pr uct ier res nse to accidents and stresses (or pressures) on the cask structure. Comment is also requested on Changes, or the net effect of multiple the appropriate parameters for facilities changes, which result in a reduction in the If such an approach is followed, the licensed under Part 72. rnargin of safety require prior NRC approval. Commission would propose to include Changes, or the net effect of multiple a definition of acceptance crf teria, such K. Safety Evaluation changes, which do not cause a reduction in as follows; Section 50.59(b)(1) requires licensees the margin of safety do not require prior NRC Acceptance criteria are those values, to maintain records that must include a approval. estabituhed by NRC regulation or review written safety evaluation that provides t.

56110 Federal Registtr/Vol. 63. No. 203/Wednisday, October 21,1998/ Proposed Rules the bases for the determination that the affecting that part of the SAR that Fuel Storage Casks, was originally change. test, or experiment does not provides sufficient information to added to part 72, no provisions were involve an unreviewed safety question. document the effect of the change upon included to address potential Section 50.59(b)(2) requires submittal of the probability or consequences of amendments of CoCs. However, e report containing a brief description of accidents or malfunctions, or reductions regulations in this area are necessary to any changes, tests, or experiment. in margin associated with that part of provide requirements for certificate including a summary of the safety the SAR. Accordingly, the Commission holders in instances where a proposed tvaluation of each. In the interest of proposes to revise 5 50.71(e) to read as change does not meet the tests of emphasizing the regulatory purpose of follows: S 72.48, and an amendment to the CoC the evaluation required under S 50.59, ..(e) Each person licensed to operate a is necessary. Therefore SS 72.244 and which led the Commission to propose nuclear power reactor pursuant to the 72.246 would be added to subpart L to deletion of the term "unreviewed safety provisions of 5 50.21 or 5 50.22 of this part provide regulations on applying for, and question." the Commission proposes to shall update periodically, as provided in approving, amendments to CoCs. delete the word " safety" in referring to paragraphs (e)(3) and (4) of this section. the Section 72.248 would also be added to the required evaluation for determining final safety analysis report (FSAR) originally provide regulations for the certificate whether the change. test or experiment submjtted p o pl at for the holder submitting an updated final requires a license amendment. For information included in the FSAR (as safety analysis report, which would purposes of the summary report of tests updated) contains the latest information document the changes it made to and experiments submitted to NRC, the developed. The submittal must describe the procedures or structures systems, and staff would propose that the rule specify effects 8 of: (1) All changes made in the components under the provisions of that a summary of the evaluation be facility or procedures as described in the S 72.48. The Commission notes that a provided (rather than a summary of the FSAR; (2) all safety analyses and evaluations general licensee is not precluded from safety evaluation). performed by the licensee either in support loading spent fuel into an appt aved A similar change is proposed for of requested license amendments, or in spent fuel storage cask during the 90-S 50.71(e), which presently refers t ku$e"a an7e day period allowed for the certificate c a end en acco safety evaluations either in support of license amendments or of conclusions with 5 50.59(c)(2) of this part; (3) all analyses holder to submit a final safety analysis of new safety issues performed by or on report. This approach is the same as that that changes did not involve USQs. The behalf of the licensee at Commission request; required for part 72 license holders to Commission proposes to change " safety and (4) the net effect of all changes made update their final safety analysis report evaluation in support oflicense since the last update on the safety analyses, under S 72.70.The Commission also amendments" to " safety analysis in including probabilities, consequences' notes, that for dual purpose spent fuel support of license amendments." to cal ulated val ss tem org po casks (i.e., casks which have been nt reduce confusion between the updated). Th'e updated information shall be issued CoCs for transportation and information prepared by the licensee for appropriately located within the update to storage under parts 71 and 72, the amendment (safety analysis) and the the FSAR. respectively), no regulation equivalent NRC review (safety evaluation). The Finally, the Commission is proposing to S 72.48 exists in part 71. second part of this phrase would be a change to the record retention Consequently. a certificate holder could revised to refer to the " evaluation that requirements in existing S 50.59 (b)(3) make changes to the design of a ment changes did not require a license (renumbered by this rulemaking to fuel storage cask under the authority of amendment in accordance with (c)(3)). The change would add to the S 72.48 (i.e., without prior NRC 5 50.59(c)(2) of this part." (In this case. requirement that the records of changes approval); however, if the change also it is a licensee evaluation against the to the facility be maintained until the affected the transportation aspects of the regulatory criteria in S 50.59 that is termination of the license, the statement cask's design and involved a being referred to). In addition, other "or until the termination of a license modification to the part 71 certificate, minor wording changes are proposed issued pursuant to 10 CFR part 54. then NRC approval and amendment of such as with respect to termi,nology on whichever is later." This change would the transportation CoC would be " final safety analysis report and make more clear the requirement that required before the cask could be used " effects of" (see reporting requirements records must be maintained through the to transport spent fuel to another site, discussion below). Conforming changes life of the facility so that they will Additionally, a transportation cask CoC in the appendices to part 52 and in part remain available until such time as they has a term of 5 years, compared to the 72 to revise language to refer t are no longer needed (that is, when the 20-year term for a storage CoC. evaluation are also proposed. license is terminated, notjust at the end Consequently, the Commission L. Reporting and Recordheeping of the initiallicensing term). envisions that most of this type of Requirements Af. Part 72 Changes change would be captured during the in view of the " minimal increase" Periodic renewal of a transportation CoC In part 72 the Commission is and this delay would not have a criteria in S 50.59 the Commission proposing to make conforming changes significant adverse impact on a equireme s or the AR update should 59 t license s ability to transport spent ruel a oe p te op S7 be enhanced to enable the NRC to better na Purpose c that holders of a Certificate of undentand the potential cumulative In S 72.3 the definition for Compliance (CoC) are also subject to it. impact of changes that might have been In addition to the proposed changes to independent spent fuelstorage made since the last update. Therefore. installation (ISFSI) would be revised to S 72.48, the Commission proposes to the Commission proposes t rem ve the tests for evaluation of the make changes in other sections of part supplement the reporting requirements

72. When subpart L-Approval of Spent acceptability of sharing common on "3ffects" of changes to require that utilities and services between the ISFS1 in the FSAR update submittal (with the and other facilities. The existing

, Ertects of changes includes appropriate replacement pages) the licensee shall revisions or descriptions in the FSAR such that the requirement in S 72.24(a)-Contents of l include a description of each change FSAR (as updated) is cornplete and accurate. application: Technical Information. 1

i 56112 Feder:1 Register /Vol. 63. No. 203/ Wednesday, October 21,1998/ Proposed Rules proposed in revised S 50,59 for Report (as updated)." The specific 10 CFR 72.212(b)(4) consistency, criteria in existing paragraph (a)(2) have 10 CFR 50.71(e) been revised to separate out the various The change to this section is to statements, to insert the language of confc,rm the reference to 10 CFR 50.59 The proposed changes to this section "more than a minimal increase," and to Provisions, specifically to change from are to conform language with respect to modify the criterion from " malfunction the terminology of unreviewed safety unreviewed safety question, safety of a different type" to " malfunction of question to referring to need for license evaluation, and reference to final safety a different result." The text for Record amendment for the facility (that is, the j (nalysis report (as updated), with the keeping requirements was revised to reactor facility at whose site the proposed language in S 50.59, and to refer to the need for license or certificate independent spent fuel storage clarify reporting requirements relating of compliance (CoC) amendments, installation is located). to " effects of" changes such that rather than involving an unreviewed 10 CFR 72'216 cumulative effects of minimal increases safety question. As pan of this revision, in probability and consequences are the Commission is also clarifying that New paragraph (d) provides included in the update to the FSAR. the records shall also provide a basis for requirements for a general licensee to 10 CFR 50.90 why a proposed change, test, or submit annual updates to a final safety experiment did not require a license or analysis report (FSAR) for the cask or A portion of existing 550.59(c) would CoC amendment with respect to casks approved for spent fuel storage be relocated into this section. This change would place the requirements significant increases in occupational cask that are used by the general for changes to technical specifications exposure or significant unreviewed licensee. The general licensee is also in the rule section on amendments to envir nmentalimpacts. Additionally, required to provide a copy of its licenses' the term Final Safety Analysis Report submittal to the certificate holder. This (FSAR) (as updated)" has been used to section is similar to the requirements in 10 CFR Part 52 provide greater clarity and consistency SS 72.70 and 72.248 for submission of with 5 50.59 and other sections of Part annual updates to the FSAR associated Appendix A and Appendix B to 10 CFR Part 52

72. The filing requirements for the with a site-specific Part 72 licensee or summary reports are modified to be a certificate holder, respectively.

The proposed changes to these consistent with S 72.4 10 CFR 72.244 sections are to conform references to (Communications). unreviewed safety question, safety evaluation and the evaluation criteria 10 CFR 72 56 This new section provides requirements for a certificate holder to concerning when prior NRC aPfroval is Existing S 72.48 (c)(2) is being submit an application to amend the needed, to the language in tne proposed relocated into this section. This is a certificate of compliance (CoC). This revision to S 50.59. parallel change to that proposed for section is similar to the requirements in 10 CFR Part 72 S 50.59 and S 50.90, wherein the S 72.56 for licensees to apply for an Commission would place the amendment to their license. 10 CFR 72.3 requirements for changes to license The definition for independent spent conditions in the rule section on 10 CFR 72.246 fuel storage installation would be amendments to licenses. This new section provides revised to remove the tests for evaluation of the acceptability of 10 CFR 72 70 requirements for approval of an amendment to a CoC. This section is sharing common utilities and services Paragraphs (a) and (b) would be similar to the requirements in S 72.58 between the ISFSI and other facilities

• revised to use the terms " Final Safety for approval of an amendment to a (Section 72.24 is also proposed to be Analysis Report," "FSAR." and "as

license, revised to include this evaluation).

updated." Paragraph (b)(2) would be 10 CFR 72.248 10 CFR 72.9 revised to add changes to procedures to the annual updates of the FSAR. New This new section provides Paragraph (b) would be revised as a Paragraph (c) would be added to requirements for submittal of annual conforming change to include in the list of information collection requirements Provide requirements on submitting updates to a FSAR associated with the revisi ns t the FSAR. the new reporting requirements in design of a spent fuel storage cask SS 72.244 and 72.248 for reports of 10 CFR 72.86 which has been issued a CoC. This new changes made by CoC holders and for section also provides that the changes to updates to the safety analysis reports by Paragraph (b) currently includes those procedures and structures, systems, and CoC holders. sections under which criminal sanctions components associated with the spent are not issued. This paragraph would be fuel storage cask and which are made 10 CFR 72.24 revised by adding SS 72.244 and 72.246 pursuant to S 72.48 would be included l This section would be revised to as a conforming change to reflect that in the annual update. The proposed j reference shared common utilities and certificate holders who fall to comply revisions would also require that the services in the applicant's assessment of with these new sections would not be certificate holder provide a copy of the potential interactions between the ISFSI subject to the criminal penalty FSAR submittal to each general licensee end another facility (previously covered provisions of section 223 of the Atomic using that cask. This section is similar by S 72.3). Energy Act (AEA). New S 72.248 has not to the requirements in S 72.70 for been included in paragraph (b) to reflect submission of annual updates to the 10 CFR 72.48 that certificate holders who fail to FSAR associated with a site-specific New definitions have been added for comply witn this new section would be part 72 license and new section 72.216 l terms such as " change" and " facility as subject to the criminal penalty for general licensees to provide updates l described in the Final Safety Analysis provisions of section 223 of the AEA. to the FSAR. l l l

Federcl Register /Vol 63, No. 203/Wednisdty. October 21,1998/ Proposed Rules 56113 IV. Commission Voting Record on graduated approach similar to the I agree with the recent letter from SECY-98-171 approaches proposed for other criteria. ACRS on this rulemaking. In that: (1) 10

2. Options for defining " minimal" as CFR 50.59 can accommodate risk-Co 1 i a posed lemaking it Patains to ",pmbability of occurrence informed decisionmaking. (2) the f an accident or probabilityof positions, as presented, on margin of package on 550.59 and related e9ul ment malfunction.

safety may add regulatory burden P regulations in SECY-98-171, dated July 10,1998. This document was placed in sagree wiIhYC r t atI el$e the Public Document Room on July 29, "p ocedu es nd tes s or I 1998. Subsequently, the Commission experiments " including elimination of (1) The rulemaking should go out for the definitions. Public comment to foster comment on ) voted to approve issuance of a proposed rule for public comments with several

4. A clear definition of" accident "

this high priority issue, and additions and changes that are reflected u d for completion (2) The regulatory guidance can be in this notice. The Commission also Oc o r 9' 1998)* worked in parallel with the rulemaking. directed that the record of their decision The Commission requests the staff t I note that a further reason for issuing on SECY-98-171 be included as part of c mplete the revised 50.59 rule on an this package for public comment at this this notice to clearly inform expedited schedule. time is that the paper calls for the proper use of enforcement discretion as stakeholders on preliminary positions (This action scheduled for completion this rulemaking progresses, thereby t< ken by the Commission. The text of February 19,1999). providing further stability in the the resultant staff requirements All Commissioners approved in part implementation of this rule in the memorandum and of the individual and disapproved in part the proposed industry, I propose that the SRM on Commissioner vote sheets, is presented rulemaking on 10 CFR parts 50,52 and

Further, below, 72 requirements concerning changes.

this SECY, and the voting record, be tests and experiments and staff placed in the FR notice to clearly inform Commission SRM on SECY-98-171, recommendations on changes to other stakeholders on preliminary posittens Dated September 25,1998 regulations and enforcement policy, and taken by the Commission. Pp ed provided additional comments. In their y p]{e vote sheets, all Commissioners Civing Definition to Minimal pu icat on for a comment period, the proposed approved the staff's recommendations to Attached to the recent ACRS letter rulemaking that would revise 10 CFR approve publication of the proposed was "A Proposal for the Development of 50.59 and related provisions in parts 50, rule for public comment, and use of the a Risk Informed Framework for 10 CFR 52 and 72 concerning the processes enf rcement discretion guidance in its 50.59 and Related Matters." The controlling licensee changes, tests and assessment of severity levels for proposal forwarded by the ACRS experiments for production and vi lations while the rulemaking is parallels an existing risk informed utilization facilities and fcr facilities for underway, and provided some approach described in Regulatory Guide independent storage of spent nuclear additional comments. In particular, all 1,174. Regulatory Guide 1.174 descr:bes fuel and high level radioactive waste. Commissioners disapproved the staff's a method for determining the level of The Voting Record, which includes the Proposed margin of safety criterion review, based on severe accident Commissioner votes and this Staff (S 50.59(c)(2)(vil) in the proposed rule) implications, for proposed beensing Requirements Memorandum, should be and its definition and each actions. The proposal forwarded by the published in the Federal Register notice Commissioner provided an option for ACRS describes methodology for to clearly inform stakeholders on evaluation during the comment period, creating frequency-consequence curves preliminary positions taken by the The Commissioners also specifically for Class 1-8 accidents. The proposal Commission (Enclosed). requested comments on a number of states that existing processes could be other issues. Because of the need to extended to provide appropriate context The Commission also approves the finalize this rule as expeditiously as for whether the results of a change are staff's recommendations for handling possible and because SECY-98-171 has " minimal." The proposal also notes that violations of 10 CFR 50.59 and 72.48, already been publicly available since aspects of this type cf approach are in including staff plans for exercise of July 29,1998, the Commission agreed to use in the internationel regulatory enforcement discretion, while a 60 day comment period, and that the community. The approech utilized in rulemaking is underway. staff complete the revised S 50.59 rule the proposal forwarded Ly the ACRS is The Commission requested that the by February 19,1999. Subsequently, the consistent with the Comtrission staff specifically solicit public comment comments of the Commission were guidance in the Staff Requ!rements in the Federal Register notice on: incorporated into the guidance to staff Memorandum of March 24,1998 on

1. A wide array of options for the as reflected in the SRM issued on SECY-97-205.

margin of safety criterion September 25,1998. Without commenting on the specifics (50.59(c)(2)(vil) in the proposed rule) f the proposal forwarded by the ACRS, Chairman Jackson's Comments on I and its definition including: (a) Deleting I am convinced that changes to nuclear SECY-98-171 the criterion and definition (b) a new plants can be evaluated in a risk-definition as described in Chairman I approve, in part, and disapprove, in informed context. Any such approach Jtekson's vote, and (c) an option which part, the staffs proposal for rulemaking. would benefit from paralleling existing would decouple the last criterion from I approve the staff's proceeding with methodology. Careful consideration technical specifications and focus issuance of the proposed rule language would be required to ensure that the instead on a new criterion relating to for public comment in order to support " consequence" and " frequency" performance of fission product barriers the expedited finalization of a revision standards are appropriate for a S 50.59 (e g., reactor coolant system pressure, to these processes. I disapprove of the type application. For instance, containment pressure, etc), with specific language proposed by the staff " consequences" could be evaluated at minimal changes being allowed up to for S 50.59(c)(2)(vil), " reductions in the one of the following levels: Fractional specified limits, perhaps utilizing a margin of safety." releases, off-site or on-site doses, or i

i i 56114 Federtl Rrgister/Vol. 63. No. 203/ Wednesday, October 21,1998/ Proposed Rules J challenges to hssion product release that the staff has met that obligation fcr proposed definition of a reduction in barriens. " Frequency" could be the " margin of safety" aspect of this the margin of safety alwaysjustify the I evaluated for Class 1-8 accidents or for proposed rule. However, this said, I do requirement of prior NRC approval. design basis accidents using existing not disagree with the staff's conclusion The staff should continue to work to guidelines for risk informed regulation, that we should be careful to understand, establish a technically sound method for The level at which consequences and and maintain, a consistent regulatory allowing licensees to make plant frequency of events were tracked would basis on " margin of safety." We must changes where there is only " minimal" riso impact the type of parallel, proceed in a manner that does not call impact on safety,if fundamental deterministic (e.g., protection of into question the existing deterministic conflicts exist with allowing reductions d redundancy, defense in depth, etc.), basis for " reasonable assurance" of in some " margins of safety," especially l considerations against which changes public safety embodied in plants those on which the validity of TSs are I would have to be evaluated. For Technical Specifications (TSs), based, then staff should provide a clear instance, evaluating consequences at the My previous discussions with the explanation of this, and should address level of the loss of a single barrier, or staff have indicated that it is extremely how other changes to the structure of occurrences of accident sequence difficult (and probably not legally the regulation, which do not create initiators, might allow elimination of defensible) to allow decreases in the fundamental conflicts, can be made in a parallel, deterministic, considerations " margin of safety" when the upper and manner which achieves the such as " margin." lower limits between which " margin" Commission's objective of removing It is of some concern to me that the may exist are not defined in relation to unnecessary burdens from licensees. whole staff has pursued risk informed the regulatory requirements for safe Attachment "A" to this vote describes approaches to issues like the review of operation. Based upon these one alternate method for addressing the TSs, the use of Graded Quality discussions,I can only assume that the issue of " margin of safety." This I Assurance, and programs like Inservice staffis hesitant to allow direct alternative would maintain existing ] Inspection and Inservice Testing, the reductions in margin within the " basis" margins of safety (associated with TSs), 4 staff appears to be more reluctant to for TSs because some such changes while providing greater flexibility to allow risk informed approaches if the could create a de-facto change in the licensees in implementing changes to i result is the relinquishment of review TSs themselves. The staff may also be their facilities. This alternative is based i and approval authority. Because prior concerned by the lack of consistency in on methodology similar to that NRC review and approval impacts the the " margin of safety in the basis for described in NEl 96-07. This j cost and schedule of licensed activities. TSs" associated with the different methodology requires evaluating the i we must ensure that we require such generations of existing licenses (e.g., effect of proposed tests and changes on j prior review and approvsl only wher older customized TSs compared to the accident analysis results (rather than Justified or required by mandate. We improved standardized TSs), and inputs. as proposed by the staff), in j should not limit the application of risk-associated with the different methods cases where TSs are based on accident informed regulation as a means to utilized in the technical review and analysis considerations. Prior NRC i ensure continued NRC reviews and approval of the TS (e g., some TSs might approval of changes, tests, and l approvals of licensed activities. This be based on maintaining margin experiments would be limited to those message is complimentary to my oft behveen accident analysis results and cases where there was a net effect on the repeated message to industry that the acceptance limits, while other TSs accident analysis results. The use of risk information is " double. might be based on rnargin which was alternative also recognizes the edged," that is that relief and additional built into analytical techniques and significance of the analytical techniques regulatory scrutiny may both result from methodologies used in the accident and used in the safety or accident analysis, its use. safety analysis, with no " margin" and would require some form of prior Ma$n /.sakty between the results and the acceptance approval for analytical methods used to limits, etc.). support changes when the change did The staff proposes to provide a The staff's proposed method of not have prior NRC approval. This specific definition of " Reduction in requiring prior agency approval to approach could provide staff reasonable margin of safety associated with any changes of input assumptions, assurance that the assumptions made by technical specification," and to revise analytical methods, etc., for those the license reviews are not invalidated. the current provisions of 10 CFR parameters which affected the selection The staff should evaluate this option. 50.59(a)(2)(iii) to explicitly refer to this of TSs results in the newly controlled along with other comments in this area, definition. While I commend the staff parameters being treated essentially the during the comment period. on its efforts to provide clear, definitive, same way as values in the TSs. It also in considering the technical and requirements in this proposed appears that implementation of the regulatory underpinning of this clause rulemaking,I am concerned that the staffs proposed control over a broad of S 50.59, I have become concerned that proposed rule is not consistent with range of parameters used in the safety we are evaluating incremental changes policy direction established by the analysis would effectively prevent any to a provision which is not well suited Commission in the SRM dated March change to the facility that would result to such changes. I am concerned that the 24,1998. I concur that it is important in a " minimal change in consequence," result may be the addition of yet another that the staff has the independence to a condition allowed elsewhere in the layer of regulatory process rather than (and, I believe, has the responsibility to) proposed rule. In other words, it is not the elimination of any unnecessary inform the Commission when there are clear what type of changes would layers. For this reason, the staff should concerns with Commission guidance (as successfully pass the 10 CFR 50.59 test be receptive to internal or public it did in COMSECY 98-013). However, for allowed " minimal increases in comments on feasible altematives I believe that when the staff proposes to consequences," without falling the test which eliminate the discussion of "the take action that is inconsistent with for "no reductions in the margin of margin of safety in the basis of TSs," Commission direction, it is obliged to safety." I do not believe that the while maintair ing the integrity of the provide a clear and complete rationale potential safety significance of allthe plant's licensing basis. I envision that it for the proposed departure. I do not feel parameters to be covered under the may be possible to eliminate the rule

i F:d:ral R:gisttr/Vol. 63, No. 203/ Wednesday, October 21,1998/ Proposed Rules 56115 Irnguage criteria on " margin of safety" Lessons-Learned Reviews," I approved upon which the selection of TS was If evaluations of " frequency" and the staff's proposal to develop the based, or in analysis where the " consequences" are performed at a level framework for risk-informed regulatory acceptability of selected TS values was of significance which bounds allowable processes. In particular, I called for the demonstrated. Licensees can make " minimal" reductions in margin. staff to develop a series of milestones by desired changes to operational which the Commission could " chart its characteristics without prior NRC Accident of a Different Type course in its move to more risk-approval, provided that the change does in determining the effect of any informed regulatory processes." not result in accident analysis results proposed change to 5 50.59,it will be Additionally,I promoted the idea of that are nearer the regulatory, or safety, necessary to more clearly understand promulgating a new regulation in 10 limits than the corresponding results what an " accident of a different type" CFR part 50, that would make clear how that the NRC used in evaluating the is. The staff should provide a more the Commission uses risk information in acceptability of the TS during licensing definitive definition of an accident than its decision-making. In proceeding with of the facility. was included in COMSECY-98-013-the "short. term" changes to 10 CFR This regufatory position could be The information provided by the staff 50.59 (and related regulations; "short. codified by adding the following should address, as a minimum, the term" actions from SECY-97-205), and footnote to Section 50.59(a)(2)(lii): following: in responding to the ACRS, the staff The " margin of safety as defined in any (1) What is an,, accident,, under this should re-evaluate whether the Agency technical specification" (margin of safety) is section, and is it consistent with other should initiate action to provide for a the amount (quantitative or qualitative) of existing regulations (e.g., S 50.92-risk informed framework that would margin between the operation of the facility 5 50.34. Appendix A of part 50, etc.)? allow for the efficiencies to be gained as described in the technical specifications (2) is an ' accident of a different type" through use of risk-informed, and the exceedance of safety limits listed in better described as an " initiating event performance-based revisions to our the technical specifications or other (e.g., loss of feedwater, loss c# offsite reguiatory processes. regulatory limits. In relation to accident power, new common mode. allure analysis, the margin of safety is typically the mechanism, etc.) of a different Type?" Attachment "A" to Chairman Jackson's vote difference between calculated parameters (3) What are the bounds which limit sheet on SECY-98-171 (e.g., peak fuel clad temperature, maximum those " accidents" which are the subject "Scraw Man"on Afargin of Satery "'ae regu or s n The of of this Section (e.g. only those initiating Regarding margin: safety is a product of specific values and events which, when evaluated using . The margin between regulatory limits limits contained in the technical approved analytical techniques, result and the failure of physical barriers is specifications (which cannot be changed in transients with the potential to protected in the regulations (and also in the without NRC approval) and other values. challenge fission product barriers, etc.)? portion of the Technical Specifications (TSs) such as assumed accident or transient initial called " safety limits"). conditions or assumed safety system Procedures . The margin, as reflected in approved response times, which are not specifically I commend staff on inserting a safety and accident analyses between the contained in the technical specifications. definition for the term " Procedures as Protection afforded by the TSs (e.g., the Any change to the values not specifically described in the final safety ana;ysis limiting safety system settings and limiting contained in technical specifications must be conditions of operations) and the associated evaluated for impact on the margin between report (as updated). However, I am regulatory limits is "the margin of safety as the calculated result of an accident or concemed that the definition provided defined in the basis for any TS." transient and the safety or regulatory limit. may cloud the distinction between: (1) . The margin between normal plant or Changes, or the net effect of multiple Those procedures which must be system operation and the " bounding" changes, which result in a reduction in the screened, or evaluated, under S 50.59. assumptions used in accident analysis is margin of safety require prior NRC approval. and (2) the criteria which necessitates a below the threshold of safety significance ChanEes, or the net effect of multiple full safety evaluation. I believe that staff that requires NRC prior approval for changes. changes, which do not cause a reduction in seeks to indicate that all rocedures . The results of safety and accident margin of safety do not require prior NRC P analyses are subject to significant variance, approval. All evaluatory work in assessing which are described as being required in depending on the analytical techniques and the impact of proposed changes must be the FSAR are subject to a S 50.59 methods used in the analysis. Where a performed using methodology and analytical screening. The screening would identify licensee wishes to make a change in their techniques which are either reviewed and the need for a full safety evaluation only facility without prior NRC approval, the approved by the NRC or which are reviewed if a proposed procedure change created effects of the change must be evaluated using and vetted in a manner approved by the NRC. a change to the "information in the analytical techniques and methods which are FSAR regarding how structures. NRC approved for the application, or which Commissioner Diaz,s Comments on systems, and components are operated are reviewed and vetted (but not subject to SECY-98-171 and controlled. ." Staff should specific NRC approval) in a NRC approved I consider this rulemaking effort to be solicit comment on this definition and our short term fix for the 50.59 rule, not clarify the proposed definition as Direct changes to technical the longer term risk-informed rule required, in the final rule. Specifications require prior NRC enhancement discussed in SECY approval. Before changing other 205. Making the Rule Risk Informed operational characteristics described in I approve the publication of this I note with interest that members of the UFSAR, a safety evaluation must be rulemaking package for a 90-day public the ACRS believe that there are performed to determine, among other comment period, contingent upon the substantial barriers in the existing things, if the change results in a additions described in the last deterministic framework of 10 CFR part reduction in the level of protection paragraph of my comments. I propose 50 to the concept of allowing " minimal" afforded by the TS (margin of safety as that the package also include the changes in accident probabilities or defined in any TS). Such a reduction Commissioners' votes for public consequences. In my previous vote on would typically occur only if the consideration. The purpose of issuing SECY-97-205. " Integration and operational characteristic had been used the rulemaking package is to expedite Evaluation of Results from Recent as a bounding condition in the analysis rulemaking by opening the process for

56116 Fed:r:1 R:gister/Vol. 63. No. 203/ Wednesday, October 21,1998/ Proposed Rules 1 public comments during the The enforcement policy and its Commissioner McGaffigan's Comments Commission's continuing deliberation corresponding implementation guidance on SECY-98-171 i on this matter. It should be made very should be changed in accordance with I approve publishing this rulemaking clear to all stakeholders that publication the revised S 50.59 rule. I recommend package for a ninety-day public of the package is an invitation to that, during the rulemaking period, the comment period. However,like my participate in improving the enforcement policy be revised to grant colleagues, I do not agree with the staff rulemaking. In fact, I do not agree with discretion (i.e., suspend issuance of proposal regarding " reduction in the several of the proposed positions in this LevelIV violations) under Section margin of safety associated with any paper, as delineated in my specific VII.B.6 for those S 50.59 violations of technical specification." comments below, little or no safety significance. As the Chairman points out, the I agree with the staff's I do not agree with the recommended definition of " reduction in margin of recommendation to remove the definitions of " facility", " procedures", safety * * *" would extend the uestion fro S 50 5 ndt make ,',' reduction in margin of safety", and requirements for prior agency approval conforming changes in parts D,52, and tests or experiments. These to underlying aspects (e.g., input

72. I also agree with staffs proposal to definitions appear to increase assumptions) of parameters that affected Prescriptiveness at the input of the the selection of technical specifications, tilow a minimalincrease in the probability of occurrence or licensees change process instead of the and result in the newly controlled consequence of an accident or utPut, and therefore, are more broad-parameters being treated essentially the based than the definitions to date. I same way as values in the technical malfunction previously evaluated, and believe that these definitions will create specifications. This is the wrong way to to not allowthe creation of an accident m re burden for the NRC and licensees, go.

of a different type or malfunction of equipment important to safety with a are not consistent with the original it is clear from my colleagues' and my intent of the 5 50 59 rule,i.e., to vote that the margin of safety criterion different result than any previously evaluated evaluate whether the licensee proposed (S 50.59(c)(2)(vil) in the proposed rule) I agree Evith the ACRS comments in changes will result in inadequate and the definition will need to be fixed their June 16,1998, letter regarding the Protection of public health and safety, in the final rule. My concern at this definition of " reduction in margin of and therefore, are not necessary. point is that the staff discuss a wide safety." Notwithstanding the staff's On the other hand. the " accident" in enough array of options in the Federal suggestion of a possible Commission the proposed revisions to S 50.59 should Register notice to ensure that the interpretation the language " altered in be defined. The " accident of a different Proposed rule wl!! not have to be a nonconservative manner" can still be type than any previously evaluated" as renoticed before being finalized. interpreted as a de facto "zero increase" described in the proposed Commissioner Diaz has proposed to i standard for the 50.59 criterion on 5 50.59(c)(2)(v) should be of the same simply delete the criterion and definition as not needed. The Chairman margin of safety. I believe the risk-safety significance as the " accident" in informed S 50.59 approach suggested in the proposed S 50.59(c)(2)(I) and has proposed essentially a new the ACRS letter deserves serious (c)(2)(lii). The staff should determine if definition. Another option would consideration as part oflonger term the anticipated operational transients decouple the last criterion from improvements and should be and the postulated design basis technical specifications and focus considered in the staff's response, due accidents described in the FSAR form a instead on a new criterion relating to 3 in February 1999, to the SRM for SECY-sufficient basis for the S 50.59 Performance of fission product barriers l 97-205. evaluation. (e.g, RCS pressure, containment The current language in pressure, etc), with minimal changes S 50.59(a)(2)(ill) (" margin of safety as being allowed up to specified limits, The staff should continue its interactions with NEI in resolving the perhaps utilizing a graduated approach defined in the basis for any technical specification") is, in fact, defined and differences between the NRC s position similar to the approaches proposed 'or bounded by the technical specifications. n S 50.59 implementation guidance other criteria. Comment should be and that contained in NEI 96-07. The Therefore, as long as the licensee 3c.: cited on this option as well. proposed change, test, or experiment regulatory guide for S 50.59 that I believe that the staff has done a good endorses a revised NEl 96-07, with under S 50.59 is not in violation of the job in proposing options for defining i technical specification requirements, exceptions and clarifications, as " minimal" for consequences of an the requisite margin of safety is appropriate, should be developed accident or malfunction. On probability, maintained, and it is possible to e ncurrently with the rulemaking however, the staff has essentially only eliminate " reduction of margin of Process. said that NEI 96-07 satisfies the safety" from the rule as a condition in summary, the staff should proceed proposed NRC standard for a " minimal" J requiring prior staff approval. This with publishing the existing rulemaking increase. That is a good step forward, l change will eliminate the existing package, and concurrently solicit public and will bring regulatory stability. I ambiguity in the use of 5 50.59 for comment on the following alternatives: believe that in choosing the word { changes with minimal safety (1) eliminate " reduction of margin of " minimal" th-Commission intended to significance. This alternative should safety" as a condition requiring prior grant greater flexibility than the NEl 96-also be published for public comment; staff approval (2) eliminate the 07 "so small" or negligible standard. it is consistent with the safety envelope b oadened definitions of " facility". The staff should continue to try to give j provided by the technical specifications " arocedures", " reduction in margin of better definition to " minimal" as it i and is a straightforward improvement safety", and " tests or experiments," and pertains to " probability of occurrence of j that will match with the eventual (3) clearly define " accident" in the an accident" or " probability of j conversion to a risk-informed rule. proposed revisions to S 50.59. I urge the equipment malfunction" and solicit I support the staff's recommended staff to complete the revised S 50.59 rule comment on this. i changes in the reporting and record and the associated regulatory guide by Finally,I endorse the use of l keeping requirements relating to S 50.59. the end of March,1999. enforcement discretion under Section

\\ Fcdtr.1 Registtr/Vol. 63, No. 203/ Wednesday, October 21,1998/ Proposed Rules 50117 Vil of the Enforcement Policy as the previously evaluated in the safety C. Afal/ unction with a Different Result rulemaking proceeds for those S 50.59 analysis report." As discussed above, As discussed above, the Commission violations of little or no safety / risk the Commission 1. proposing a more significance. The staff should treat (vice than minimally increased" criterion. 15 Proposing to adopt this particular " consider treating" as proposed by staff) which is considered comparable in Proposed change to the rule, ts minor violations cases where the overall intent to what was proposed by D. Margin ofSafety Provided by Any violation of existing rule requirements NEl. Technical Spec 1/1 cation would not constitute a violation under B. Increa<e in Consequences of an NEl proposes to replace the existing the rule were it revised as proposed. I Accident or Malfunction language of "as defined in the basis for do not object to documenting such minor violations in inspection reports NEI proposes that the rule be revised any technical specifications," with "as because the rule is still in a proposed such that a change would be a USQ if provided by any technical revision stage. the consequences of an accident or specification" with respect to malfunction previously evaluated reductions in the margin of safety. The V. Rule Language Proposed by The exceed the established acceptance limit. pr p sed change is intended to clarify Nuclear Energy Institute As NEl discusses further in its letter, the that the margin of safety is not In a letter dated November 14,1997, established acceptance limit would be necessarily limited to information in the BASES section of the technical the Nuclear Energy Institute provided to the value tht was previously reviewed the NRC suggested language for revising and approved oy the NRC generally as specification. NEI 96-07 guidance notes that the SAR. staff SERs and other 10 CFR 50.59 that they believed would documented in the staff s safety enable the NRC to endorse NEl 96-07. evaluation report (SER). licensing basis documents should be This language is included here in this The current industry guidance, NEI reviewed to determine if a proposed Statement of Considerations so that 96-07, would permit, in some instances, change would result in a reduction in i interested parties can offer comment on increases in consequences up to the margin of safety. NEIintended to use whether this language should be regulatory thresholds (such as Part 100), this rule language in conjunction with adopted by the NRC. The supporting without review. As discussed in (draft) guidance that the margin of safety is the information for NErs proposalis NUREG-1606, the staff typically range of values between the acceptance contained in the referenced letter which Performs independent evaluations of limit reviewed by the NRC (e.g., ASME is available for review in the Public radiological consequences of accidents, code stress limits, containment design Document Room. rather than an in-depth review of the pressur' etc.) and the failure point. The Specifically. NE! proposed that licensee's calculations. during licensing Commission is seeking comment on a lexisting] section 50.59(a)(2) be revised of the plant. As a result, the degree of ranse of options relating to margin of to read: conservatism in the licensee safety, including the option proposed by (a)(2) A proposed change, test, or calculations differs from that used in the NEl. experiment shall be deemed to involve an staff's assessments. As noted above, the VI. Request for Comment unreviewed safety question: (i) If there is Commission is proposing to revise the more than a negligible increase in the rule to allow minimal increases in The Commission re9uests comments probability of occurrence of an accident or consequences without prior approval, n the proposed rule, as discussed in Section 11 above. In addition, the malfunction of equipment important to safety provided that the regulatory limits are previously evaluated in the safety analysis still met. The Commission has some Commission is seeking comment on a report; or (ii) if the consequences of an accident or malfunction important to safety concerns about allowing licensee number of specific issues related to this previously evaluated in the safety analysis changes without review, which when rulemaking. All commenters are l rrport exceeds the established acceptance evaluated with licensee assumptions encouraged to provide specific i limit; or (ui) if a possibility for an accident and methods, result in doses at or very comments on the following issue areas: of a different type or malfunction with a close to the regulatory guidelines (e.g.,

1. The Commission is seekin8 i"Put different result from any evaluated part 100). This is because such changes.

n a number of options relating to the previously in the safety analysis report may if reviewed with staff assumptions (or crueri n f margin of safety reduction, be created; or (tv) if the margin of safety starting from the staff's previous and its definition. Some possible provided by any technical specification is d"'*d' estimation of the accident dose), might alternatives are presented in Section IIJ result in the regulatory guidelines not as being rt;iresentative of the range of l In this rulemaking. the Commission is being met. Rather than allowing one approaches under consideration, but the proposing to adopt certain aspects of the change to result in an increase in Commission is open to other proposals changes offered by NEl (e.g., on consequences up to the guidelines. the that commenters may wish to put forth malfunction with a different result). The Commission concludes that minimal a5 representing the best means to Commission is seeking comment as to increases, along with NRC oversight of Provide a clear understanding of which j whether other aspects of this proposal cumulative effects, is the appropriate margins should fall within the should be adopted. The Commission standard for review. regulatory envelope of requ! ring also offers the following observations approval if they would be reduced as a about this proposal for consideration as

• Attempting to use values from the staff s SER as result of a change, test or experiment,if part of the comment process:

acceptance limits would be dimcult since SERs the margin of safety criterion were to be were not written for the purpose of establishing retained. A. Negligible Increase in Probabilify of such hrnits in a literal sense. neither the SAR nor

2. The Commission is interested in l

Occurrence the SER set an " acceptance hma",Rather, the SAR options for defininE what constitutes a documents an applicant's/ licensee s analytically NEI proposes that the rule be revised derived conclusion that a given event has a certain " minimal" increase in the probability of to state that a change would be an USQ consequence which is within the regulatory bounds occurrence of an accident previously "if there is more than a negligible set by NRC regulations The SER is intended only evaluated in the FSAR or in the increase in the probability of occurrence ',i,,"[, nb'"Nr u*g'h he probability of equipment malfunction h re w nd of an accident or malfunction of approval then becomes the baseline for future (refer to Section li.G). This might equipment important to safety analyses. Include suggested examples of changes

56118 Ftd:rcl R:gistir/Vol. 63, No. 203/ Wednesday, October 21,1998/ Proposed Rules i that commenters believe represent only adopted, will not have a significant Commission estimates that this is a c " minimal increase" in probability, impact on the environment. The small increment over the existing

3. The Commission is interested in proposed rule changes are of two types: burden. On the other hand some comments upon the proposed those that relate to the processes for changes might be screened out as not definitions for such terms as " facility as evaluating and approving changes to needing evaluation on the basis of these described in the FSAR." " procedures as licensed facilities and those that involve definiticas, and thus there would described in the FSAR." and " tests or the degree of potential change in safety overall be at most a small increase in the experiments" (refer to Sections ll.B. C, for which changes can proceed without record keeping required, cnd D). The Commission is soliciting NRC review. The process changes being In addition, the requirements under views on whether (1) definitions are proposed will make it more likely that S 72.48 are also being revised to necessary. (2) the proposed definitions planned changes are properly reviewed explicitly require records of are desirable, even if not necessary, and and approved by NRC when necessary.

determinations concerning occupational (3) whether the suggested definitions are With respect to the criteria changes, dose and environmentalimpact (the clear and focused upon the appropriate only minimal increases in probability or existing rules required the evaluations changes that should be evaluated. In consequences of accidents (still but did not explicitly specify record this light. the Commission is also satisfying regulatory limits) would be retention requirements for these interested in comments on a broader allowed without prior NRC review. All evaluations). The Commission does not view of the scope of changes that should changes to the Technical Specifications, believe this that this change will be evaluated; for instance, should the which are the operating limits and other significantly impact record keeping scope be linked to the SAR, or should parameters of most immediate concern burden because records of evaluations the focus of changes to the facility be for public health and safety, will of changes are already required (as to linked to another set of regulatory continue to require prior NRC review whether they involve a USQ), and the information? and approval. Changes to the facility evaluation itself is already required by

4. As part of the present rulemaking, that would involve an accident of a the rule. The part 72 burden associated the Commission is seeking comment on different type from any already with the definitions of when es aluations the need f or a clear definition of analyzed, or reductions in defined are required should be signific mtly less accident as it is used in S 50.59 to reflect margins of safety require prior approval. than for S 50.59 since the num ter of the Con' mission's intent that the Further, changes which result in more licensees is smaller and the expected

" accidents" referred to are those dealt than minimal increases in radiological number of changes is also smaller, with in the safety analysis report (see consequences will continue to require Further, there is a recordkeeping Section II.H of this notice for discussion prior NRC approval, including NRC requirement established for CoC holders of issues related to definition of consideration of potential impact on the who make changes to an approved accident). environment. Therefore, the storage cask design in accordance with

5. In addition to the NRC proposals in Commission concludes that there will S72.48.

Sections 11 and 111. the Commission is be no significant impact on the With respect to reporting also interested in receiving comments environment from this proposed rule. requirements, the Commission is on the proposals and language suggested This discussion constitutes the proposing to modify the FSAR update by NEl (Section V). environmental assessment and finding requirement to state that the updates j VII. Availability of Documents and of no significant impact for this must include specific information on i Electronic Access proposed rule. the effects of changes made. This was not explicitly stated in the current rule, Certain documents related to this 11 Paperwork Reduction Act although it could be inferred that this Statement rulemaking, including comments was what the update rule intended, as rec :ived and the regulatory analysis, This proposed rule amends follows. In the Statement of j maj be examined at the NRC Public information collection requirements that Considerato as for 5 50.71(e).(45 FR Document Room,2120 L Street NW. are subject to the Paperwork Reduction 30615), the NRC commented on the This rule IL(44 U.S.C. 3501 et seq.). relationship between changes made Act of 1995 (Lower Level). Washington, DC NRC documents also may be viewed and been submitted to the under S 50.59 and FSAR updating, i downloaded electronically via the Office of Management and Budget for stating: "The S 50.59(b) reporting may l interac!"e rulemaking website review and approval of the inform 6on not be detailed sufficiently to be j established tiy NRC for this rulemaking. collection requirements. Existing considered adequate to fulfill the FSAR i You may also provide comments via requirements were approved by the updating requirement. The degree of the NRC's interactive rulemaking web Office of Management and Budg et detail required for updating the FSAR { site through the NRC home page (http:/ approval numbers 3150-00' ; ad 3150- will be generally greater than a 'brief /www.nrc. gov). This site provides the 0132. description' and a ' summary of the availability to upload comments as files The proposed rule changes would safety evaluation'." Thus, the (any format). If your web browser affect information collection Commission clearly expected the update supports that function. For information requirements through the existing submittal to include sufficient l about the interactive rulemaking site, reporting requirements in S 50.59 for a information to appropriately reflect the I contact Ms. Carol Gallagher. (301) 415-summary report of changes, tests and changes that were made. The burden j 5905; e-mail CAG@nre. gov, experiments, performed under the associated with explicitly documenting i authority of S 50.59 and in S 50.71(e) for in the update the effects of the changes VIII. Finding of No Significant submittal of updates to the FSAR, as on event probabilities and consequences EnvironmentalImpact well as record keeping requirements. To is therefore small. The Commission has determined the extent that the definitions provided The public reporting burden for this under the National Environmental in the proposed revisions would require information collection request is Policy Act of 1969 as amended, and the evaluations that are not presently being estimated to average 3100 hours per Commission's regulations in subpart A performed, there may be an increase in response, including the time for of 10 CFR part St. that this rule, if record keeping and reporting. The reviewing instructions, searching

Federel R:glit:r/Vol. 63. No. 203/ Wednesday October 21,1998/ Proposed Rules 56119 existing data sources, gathering and Public Document Room. 2120 L Street XIV. Compatibility of Agreement State maintaining the data needed, and NW. (Lower Level). Washington, DC and Regulati<ms completing and reviewing the is available through the NRC interactive Under the " Policy Statement on information collection. The Commission rulemaking website. Single copies of the Adequacy and Compatibility of estimates that there is only a slight analysis may be obtained from Eileen Agreement State Programs" approved by increase in burden associated with these McKenna. EMM@NRC. GOV (301) 415-the Commission on June 30.1997, and proposed changes over the existing 2189, Mail stop O-11-F-1, U.S. Nuclear published in the Federal Register (62 burden. The U.S. Nuclear Regulatory Regulatory Commission, Washington DC FR 46517 September 3,1997), this rule Commission is seeking public comment 20555. Is classified as compatibility Category on the potential impact of the collection The Commission requests public "NRC." Compatibility is not required for of information contained in the comment on the deaft analysis. Category NRC" regulations. The NRC proposed rule and on the following Comments on the draft analysis may be program elements in this category are issues: submitted to the NRC as indicated those that relate directly to areas of

1. Is the proposed collection of under the ADDRESSES heading.

regulation reserved to the NRC by the informa:lon r.ecessary for the proper performance of the functions of the XI. Regulatory Flexibility Certification AEA or the provisions of Title 10 of the Code of Federal Regulations. and NRC, including whether the information in accordance with the Regulatory although an Agreement State may not will have practical utility? Flexibility Act of 1980, (5 U.S.C. adopt pogram elements reserved to

2. Is the estimate of the burden 605(b)), the Commission certifies that NRC. It may wish to inform its licensees correct?

3. Is there a way to enhance the this rule will not, if promulgated, have of certain requirements via a mechanism a significant economic impact on a that is consistent with the particular quality, utility, and clarity of the substantial number of small entities.

State's administrative procedure laws. o ca th urd fthe This proposed rule affects only the but does not confer regulatory authority collection of information be minimized, licensing and operation and on the State. Including the ur.e of automated decommissioning of nuclear power List of Subjects plants, nonpower reactors, and entfon any aspect of this independent spent fuel storage facilities. 10 CFR Part 50 end corn proposed collection of information. The companies that own these facilities Antitrust Classified Information, including suggestions for reducing the do not fall within the scope of the Criminal penalties. Fire protection, burden. t.s the Information and Records definition of,small entities set forth in Intergovernmental relations, Nuclear Msnagemer t Branch (T-6 F33), U.S. the Regulatory Flexibility Act or the power plants and reactors. Radiation Nuclear Regulatory Commission. Small Business Size Standards set out in protection. Resctor siting criteria, Washington. DC 20555-0001, or by regulations issued by the Small Reporting and record keeping Internet electronic mail at Business Ariministration at 13 CFR part requirements. BJSl@NRC.COV; and to the Desk I2I' 10 CFR Part 52 Officer Office ofInformation and XIL Backfit Analysis Regulatory Affairs NEOB-10202 Administrative peactice and (3150-0017. -002d. -0011. -0009, and As required by S 50.109 and S 72.62, procedure Antitrust, Backfitting. -01320), Office of Management and the Commission has completed a backfit Combined license. Early site permit. analysis for the proposed rule, which is Emergency planning. Fees, inspection, Budget. Washirbton. DC 20503' lections included within the regulatory analysis. Limited work authorization. Nuclear Commems to MB on the col of information or on the above issues The Ccmmission has determined, based power plants and reactors Probabilistic should be submitted by November 20. on this analysis, that in most respects, risk assessment Prototype, Reactor 1998. Comments received after this date the proposed rule does not impose new siting criteria, Redress of site, Reporting will be considered if it is nractical to do requirements, but provides more and record keeping requirements, so, but assurance of consideration flexibility or clarification of existing Standard design Standard design cannot be given to comments received requirements. In other respects, such as certification. after this date. the definitions of change to the facility 10 CFR Part 72 and *, reduction of margin of Public Protection Not1/1 cation safety * * *", some licensees may view Manpower training programs, Nuclear The NRC may not conduct or sponsor, the revised rule as imposing new materials. Occupational safety and and a perron is not required to respond requirements. Therefore, the health. Reporting and record keeping to, a collection of information imless it Commission has prepared an analysis requirements. Security measures, Spent displays a currently valid OMB control considering the factors in S 50.109(c), fuel number. which is included in the Regulatory For the reasons set out in the Analysis. Preamble and under the authority of the X, Regulatory Analysis Atomic Energy Act of 1954, as amended. IIL Criminal Penahles The Commission has prepared a draft the Energy Reorganization Act of 1974. regulatory analysis on this proposed For the purposes of Section 223 of the as amended, and 5 U.S.C. 553. the NRC regulation. The analysis examines the Atomic Energy Act (AEA), the 15 Proposing to adopt the following values and impacts of the alternatives Commission is issuing the proposed amendments to 10 CFR parts 50. 52 and considered by the Commission and rule to amend 10 CFR part 50 : 50.59.: 72. includes the backfit analysis required by 50.66, and : 50.71; and 10 CFR part 72: S 50.109 (and S 72.62). The altenatives 72.48,: 72.70,: 72.212, and : 72.248. PART 50-DOMESTIC LICENSING OF PRODUCTION AND UTILIZATION considered in this analysis include no under one or more of sections 161b. FACILITIES action. issuance of guidance only, or 1611. or 161o of the AEA. Willful I rulemaking. The draft malysis is violations of the rule would be subject

1. The authority citation for part 50 available for inspection in the NRC to criminal enforcement.

continues to read as follows:

56120 Fed:ral Rrgist:r/Vol. 63. No. 203/ Wednesday, October 21,1998/ Proposed Rules Authority: Secs. 102.103,104.105,161. components are operated and controlled updated), or in evaluations performed 182,183.186.189. 68 Stat. 936. 937,938. (including assumed operator actions pursuant to this section and safety a 948. 953, 954, 955, 956, as amended. sec. and response times) and information analyses performed pursuant to S 50.90 234. 83 Stat.1244, as amended (42 U.S.C. describing the conduct of operations. after the last final safety analysis report ended l (5) Reduction in margin ofsafety was updated pursuant to S 50.71 of this ) .s 202. 206. 88 Stat.1242. as amended.1244, associated with any technical part; 1246 (42 U.S.C. 5841,5842,5846). Specification means that the input (ii) Result in more than a minimal Section '.,0.7 also issued under Pub. L. 95 assumptions, analytical methods, increase in the probability of occurrence 601, sec.10,92 Stat. 2951 (42 U.S.C. 5851). acceptance conditions, criteria and of a malfunction of equipment Section 50.10 also issued under secs.101, limits of the safety analyses, presented important to safety previously evaluated 185,68 Stat. 955 as amended (42 U.S.C. 2131, in the final safety analysis report (as in either the final safety analysis report 2235). sec.102 Pub. L. 91-190,83 Stat. 853 updated), that established any technical (as updated), or in evaluations (42 U.S.C. 4332). Sections 50.13, and specification requirement, are altered in performed pursuant to this section and 50.54(dd), and 50.103 also issued under sec. a nonconservative manner. safety analyses performed pursuant to 8 a 9 (6) Tests or experiments not described S 50.90 after the last final safety analysis 0 23 50 35 50.55 n 50.56 also issued under sec.185. 68 Stat. 955 (42 in the final safety analysis report (as report was epdated pursuant to S 50.71 U.S C. 2235). Sections 50.33a,50.55a and updated) means any condition where of this part: Appendix Q also issued under sec.102. Pub. the reactor or any of its systems, (111) Result in more than a minimal L. 91-190,83 Stat 853 (42 U.S.C. 4332). structures or components are utilized or increase in the consequences of an Sections 50.34 and 50.54 also issued under cc,ntrolled in a manner which is either: accident previously ev luated in either sec. 204,88 Stat.1245 (42 U.S C. 5844). (1) Outside the controlling parameters the final safety analysis report (as Section 50.37 also issued under E.O.12829. of the c esign bases as described in the updated), or in evaluations performed 3 CFR 1993 Comp., P. 570. E.O.12958. final safety analysis report (as updated) pursuant to this section and safety Sections 50.58. 50.91, and 50.92 also issued or analyses performed pursuant to S 50.90 ne ns ent M h ana% in ak h lam nnM sa% anaWs rep .C 2 9 t on 50 78 a s ssu under sec.122,68 Stat. 939 (42 U.S.C. 2152). the final safety analysis report (as was updated pursuant to S 50.71 of this Up(dated). part; Sections 50.80-50.81 also issued under sec. b) Applicability.The provisions of (iv) Result in more than a minimal 184,68 Stat. 954. as amended (42 U.S.C. 2234). Appendix 3: also issued under sec. this section apply to each holder of a increi,se in the consequences of a 187,63 Stat. 955 (42 U.S.C 2237). license authorizing operation of a malfunction of equipment important to

2. Section 50.59 is revised to read as production or utilization facility, safety previously evaluated in either the including the holder of a license final safety analysis report (as updated),

foijnw3' authorizing operation of a nuclear or in evaluations performed pursuant to $ 50.59 Changes, tests and experiments. power reactor that has submitted the this section and safety analyses (a) Definitions for the purposes of this certification of permanent cessation of performed pursuant to S 50.90 after the section: operations required under S 50.82(a)(1) last final safety analysis report was (1) Change means a modification, or a reactor licensee whose license has up(dated pursuant to S 50.71 of this part; v) Create a possibility for a design addition or removal, been permanently modified to allow (2) Facility as described in the final possession but not operation of ihe basis accident of a different type than safetyanalysis report (as updated) facility. any previcesly evaluated in either the means: (c)(1) A licensee may make changes in final safe.y analysis report (as updated), (1) The systems structures, and the facility as described in the final or in evaluations performed pursuant to components that are described in the safety analysis report (as updated), make this section and safety analyses final safety analysis report (as updated), changes in the procedures as described performed pursuant to S 50.90 with (11) The design, performance in the final safety analysis report (as respect to design basis accidents after requirements and methods of operation updated), and conduct tests or the last final safety analysis report was for such systems, structures and experiments not described in the final updated pursuant to 5 50.71 of this part; components required to be included or safety analysis report (as updated) (vi) Create a possibility for a described in the final safety analysis without obtaining a license amendment malfunction of equipment important to report (as updated), and pursuant to S 5030 only if: safety with a different result than any (iii) The evaluations or methods of (1) A change to the !? chnical previously evaluated in either the final evaluation required to be included in specifications ImcGrporated in the safety analysis report (as updated), or in the FSAR (as updated) for such SSC and license is not required arH evaluations performed pursuant to this which demonstrate that their intended (11) The charige. t3st c experiment section and safety analyses performed function (s) will be accomplished. does not meet any of the criteria in pursuant to 5 50.90 after the last final (3) Finalsafety analysis report (as paragraph (c)(2) of this section. The safey analysis report was updated updated) means the Final Safety provisions in this section do not apply pursuan' to S 50.71 of this part: Analysis Report (or Final Hazards to changes in procedures when the (vil) Result in a reduction in the Summary Report) submitted in applicable regulations establish more margin of safety associated with any tccordance with $ 50.34, as amended specific criteria for accomplishing such Technical Specification. and supplemented, and as modified as changes. (d)(1) The licensee shall maintain a result of changes made pursuant to (2) A licensee shall obtain an records of changes in the facility and of S 50.59 and S 50.90, and, as applicable, amendment to the license pursuant to changes in procedures made pursuant to S 50.71 (e) and (f). S 50.90 prior to implementing a change. this section, to the extent that these (4) Procedures as describedin the test or experiment ifit would: changes constitute changes in the final safety analysis report (as updated) (1) Result in more than a minimal facility as described in the final safety means information in the final safety increase in the probability of occurrence analysis report (as updated) or to the analysis report (as updated) regarding of an accident previously evaluated in extent that they constitute changes in how structures. systems, and either the final safety analysis report (as procedures as described in the final

Feder:1 Registir/Vol. 63. No. 203/Wedn:sday, October 21,1998/ Proposed Rules 56121 safety analysis report (as updated). The the Requalification Inspection and Test requirements of paragraph (f)(2) of this licensee shall also maintain records of Program, the licensee shall submit a section have been met. tests and experiments carried out summary oflack of compliance with the pursuant to paragr9ph (c) of this section. Thermal Annealing Operating Plan and

4. In $ 50.71 paragraph (e) is revised These records must include a written the Requalification Inspection and Test to read as follows:

evaluation which provides the bases for Program and ajustification for the determination that the change, test subsequent operation to the Director, 6 50.71 Maintenance of records, making of or experiment does not require a license Office of Nuclear Reactor Regulation. '*P*"** amendment pursuant to paragraph (c)(2) Any changes to the facility as described cf this section. In the final safety analysis report (as (e) Each person licensed to operate a (2) The licensee shall submit, as updated) whkh are attributable to the nuclear power reactor pursuant to the specified in S 50.4, a report containing noncompliances and which require a provisi ns of S 50.21 or S 50.22 of this a brief description of any changes. tests, license amendment pursuant to Part shall update periodically, as and experiments, including a summary 5 50.59(c)(2) and any changes to the Provided in paragraphs (e)(3) and (4) of of the evaluation of each. The report technical specifications, shall also be this section, the final safety analysis may be submitted annually or along identified. report (FSAR) originally submitted as with the FSAR updates as specified by (1)If no changes requiring a license part of the application for the operating license, to assure that the information S 50.71(e), or at such shorter intervals as amendment pursuant to S 50.59(c)(2) or may)be specified in the license. changes to Technical Specifications are included in the report contains the (3 The records of changes in the identified, ue licensee may restart its latest information developed. This fulity must be maintained until the reactor after the requirements of submittal must contain all the changes terrrination of a license issued pursuant paragraph (f)(2) of this section have necessary to reDect infonnation and analyses submitted to the Commission to this part or the termination of a been met, by the licensee or prepared by the license issued pursuant to 10 CFR part (ii) If any changes requiring a license licensee Pursuant to Commission 54, whichever is later. Records of amendment pursuant to 550.59(c)(2) or requirement since the submission of the changes in procedures and records of changes to the Technical Specifications riginal FSAR, or as appropriate the last tests and experiments must be are identified, the licensee may not u ae e un s secdon. maintained for a period of five years-restart its reactor until approval is

3. In 5 50.66, paragraph (b)-

obtained from the Director, Office of T,he submittal must include the effects I introducto text, paragraphs (b)(4)> Nuclear Reactor Regulation and the (1) All changes made in the facility or (c) 2) and (3)(111) are revised to read requirements of paragraph (f)(2) of this procedures as described in the FSAR: section have been met. (2) All safety analyses and evaluations 9 50.66 Requirements for thermal (3) * *

• performed by the licensee either in annealing of the reactor pressure vessel.

(ill) If the partial annealing was not support of requested license performed in accordance with the amendments, or in support of (b) Therma 1 Annealing Report. The Thermal Annealing Operating Plan and conclusions that changes did not require Thermal Annealing Report must the Requalification Inspection and Test a license amendment in accordance include: a Thermal Annealing Operating Program, the licensee shall submit a with 5 50.59(c)(2) of this part; Plan; a Requalification Inspection and summary of lack of compliance with the (3) All analyses of new safety issues Test Program; a Fracture Toughness Thermal Annealing Operating Plan and performed by or on behalf of the Recovery and Reembrittlement Trend the Requalification Inspection and Test licensee at Commission request; and Assurance Program; and Identification Program and ajustification for (4) The net effect of all changes made of Changes Requiring a License subsequent operation to the Director, since the last update on the safety Amendment. Office of Nuclear Reactor Regulation. analyses, including probabilities, (1) * *

• Any changes to the facility as described consequences, calculated values, system (4) Identification of changes requirfng in the final safety analysis report (as or component performance, that are in a license amendment. Any changes to updated) which are attributable to the the FSAR (as updated). The updated the facility as described in the final noncompliances and which require a information shall be appropriately safety analysis report (as updated) license amendment pursuant to located within the update to the FSAR.

which requires a license amendment S 50.59(c)(2) and any changes to the pursuant to S 50.59(c)(2) of this part, technical specifications which are

5. Section 50.90 is revised to read as and any changes to the technical required as a result of the follows:

specifications, which are necessary to noncompliances, shall also be $ 50.90 Application for Amendment of either conduct the thermal annealing or identified. license or contNetion permit. to operate the nuclear power reactor (A) If no changes requiring a license Whenever alder of a license or following the annealing must be amendment pursuant to S 50.59(c)(2) or identified. The section shall changes to technical specifications are constructiu permit desires to amend the license (including the Technical demonstrate that the Commission's identified, the licensee may restart its Specifications incorporated into the requirements continue to be complied reactor after the requirements of license) or parmit, application for an with, and that there is reasonable paragraph (f)(2) of this section have amendment must be filed with the assurance of adequate protection to the been met. Commission, as specified in S 50.4, fully public health and safety following the (B) If any changes requiring a license describing the changes desired, and changes., amendment pursuar t to S 50.59(c)(2) or following as far as applicable, the form (c) *

• changes to technical specifications are prescribed for original applications.

(2) If the thermal annealing was identified, the licensee may not restart ecmpleted but the annealing was not its reactor until approval is obtained , Enects or es includes appropriate performed in accordance with the from the Director, Office of Nuclear revisions of descriptions in the FSAR such that the Thermal Arnealing Operating Plan and Reactor Regulation and the FSAR (as updated) is complete and accurate."

F' 56122 Federal Register /Vol. 63, No. 203/W:dnesday. October 21,1998/ Proposed Rules PART 52-EARLY SITE PERhMTS,

d. lf a departure requires a license Specification for an application or license STANDARD DESIGN amendment pursuant to paragraphs B.S.b or referencing this design cenification.

CERTIFICATIONS; AND COMBINED B.S.c of this section, it is govemed by 10 CFR "0.90. LICENSES FOR NUCLEAR POWER

d. If a departure requires a licens '

PLANTS amendment pursuant to paragraphs L.5.b or B.S.c of this section, it is governed by 10 CFR 6.The authority citation for part 52 X. Records and Reporting 50.90. continues to read as follows: A. Records. Authority: Secs. 103,104.161.182,183. 186.189. 68 Stat. 936. 948,953. 954. 955,

3. An applicant or licensee who refer =Aes X. Records and Repordn8 956. as amended, sec. 234,83 Stat.1244 as this appendix shall prepare and maintain A. Records.

trnended (42 U.S.C. 2133,2201. 2232. 2233. written evaluations which provide the bases 4 2236, 2239, 2282); secs. 201, 202. 206. 88 for the determinations required by Section Stat.1242.1244.1246, as amended (42 U.S.C. VIII of this appendix. These evaluations must

3. An applicant or licensee who references 5841.5842.5546).

be retained throughout the period of this appendix shall prepare and maintain application and for the term of the license written evaluations which provide the bases

7. Appendix A to Part 52 is amended (including any period of renewal).

for the determinations required by Section i by revising Section Vill.B. paragraphs VIII of this appendix. These evaluations must 5.a.b.d. and Section X.A.3 as follows:

8. Appendix B to part 52 is amended be retained throughout the period of j

Aopendix A-Design Certification Rule by revising Section VIII.B. paragraphs ap lication and fo e term o license 5.a.b.d. and Section X.A.3 to read as for the U.S. Advanced Boiling Water Reactor f 11 ws. PART 72-LICENSING 171L Processes for Changes and Departures Appendix B-Design Certification Rule REQUIREMENTS FOR THE for the System 80+ Design INDEPENDENT STORAGE OF SPENT i NUCLEAR FUEL AND HIGH-LEVEL 1 B. Tier 2 information 17II. Processes for Changes and Departures RADIOACTIVE WASTE 5*** a.' An applicant or licensee who references B. Tier 2 information.

9. The authority citation for part 72 this appendix may depart from Tier 2 continues to read as follows:

information, without prior NRC approval unless the proposed departure involves a'

a. An applicant or licensee who references Authority: Secs. 51,53.57.62,63.65.69.

change to or departure from Tier I this appendix may depan from Tier 2 81,161.182.183.184.186.107,189. 68 Stat. information. Tier 2* information, or the information, without prior NRC approval. 929,930,932,933.934,935,948,953.954, technical specifications, or otherwise unless the proposed departure involves a 955. as amended, sec. 234, 83 Stat. 444, as requires a license amendment as defined in change to or departure from Tier 1 amended (42 U.S.C. 2071. 2073,2077. 2092, paragraphs B.S.b and B.5.c of this section. inf rmation. Tier 2* Information, or the 2093,2095.2099,2111,2201.2232.2233, 2234, 2236. 2237, 2238, 2282); sec. 274. Pub. When evaluating the proposed departure, an technical specifications. or otherwise L. 86-373,73 Stat. 688, as amended (42 applicant or licensee shall consider all requires a license arnendment as defined in U.S.C. 2021); sec. 201, as amended. 202.206, matters described in the plant-specific DCD. Paragraphs B.S.b and B.S.c of this section. 88 Stat.1242 as amended. 1244.1246 (42

b. A proposed departure from Tier 2. other When evaluating the proposed departure, an U.S.C. 5841, 5842. 5846); Pub. L. 95-601, sec.

than one affecting resolution of a severe applicant or licensee shall consider all 10,92 Stat. 2951 (42 U.S.C. 5851); sec.102. tecident issue identified in the plant-specific matters described in the plant-specific DCD. Pub. L. 91-190. 83 Stat. 853 (12 U.S.C. 4332); DCD, requires a license amendment if it

b. A proposed departure from Tier 2. other Sees.131.132,133.135.137.141. Pub. L.

would-than one affecting resolu*jon of a severe 97-425. 96 Stat. 2229,2230. 2232. 2241. sec. (1) Result in more than a minimal increase accident issue identified in the plant specific 148. Pub. L.100-203,101 Stat.1330-235 (42 in the probability of occurrence of an DCD. requ9es a license amendment if it U.S.C.10151.10152.10153.10155.10157, accident previously evaluated in the plant, would-10161,10168). specific DCD; (1) Result in more than a minimal increase Section 72.44(g) also issued under secs. (2) Result in more than a minimal increase in the probability of occurrence of an 142(b) and 148(c). (d). Pub. L. 100-203,101 in the probability of occurrence of a accident previously evaluated in the plant-Stat.1330-232.1330-236 (42 U.S C. malfunction of equipment important to safety specific DCD; 10162(b) 10168(c). (d)). Section 72.46 also previously evaluated in the plant-specific (2) Result in more than a minimal increase issued under sec.189. 68 Stat. 955 (42 U.S.C. DCD; in the probability of occurrence of a 2239); sec.134. Pub. L. 97-425. 96 Stat. 2230 (3) Re2. ult in more than a minimal increase.nalfunction of equipment important to safety (42 U.S.C.10154). Section 72.96(d) also in the consequences of an accident previously evaluated in the plant-specific issued under sec.145(g). Pub. L.100-203. previously evaluated in the plant-specific DCD; 101 Stat.1330-235 (42 U.S.C.10165(g)). DCD; (3) Result in more than a minimal increase Subpart j also issued under secs. 2(2). 2(15). (4) Result in more than a minimal increase in the consequences of an accident 2(19),117(a) 141(h). Pub. L. 97-425. 96 Stat. in the consequences of a malfunction of previously evaluated in the plant specific 2202,2203. 2204,2222. 2224 (42 U.S.C. equipment important to safety previously DCD; 10101,10137(a).10161(h)). Subparts K and L svaluated in the plant specific DCD; (4) Result in more than a minimal increase are also issued under sec.133,98 Stat. 2230 (5) Create a possibility for a design basis in the consequences of a malfunction of (42 U.S.C.10153) and sec. 218(a). 96 Stat. cccident of a different type than any equipment important to safety previously 2252 (42 U.S.C.10198). evaluated previously in the plant-specific evaluated in the plant-specific DCD;

10. Section 72.3 is amended by revising e

on or in& pen &nt spent

6) Create a possibility for a malfunction of ac en of a d e t

th equipment important to safety with a evaluated previously in the plant specific fuel storage installation or ISFSI to read different result than any evaluated previously DCD. as follows: in the plant-specific DCD; or (6) Create a possibility for a malfunction of (7) Result in a reduction in the margin of equipment important to safety with a safety associated with any Technical different result than any evaluated previously Specification for an application or license in the plant specific DCD; or Independent spent fuelstorege referencing this design certification-(7) Result in et reduction in the margin of installation orISFSimeans a complex safety associated with any Technical designed and constructed for the

F ('9 Fed:r:1 R: gist:r/Vol. 63, No. 203/ Wednesday, OctoLer 21,1998/ Proposed Rules 56123 interim storage of spent nuclear fuel and a result of changes made pursuant to or spent fuel storage cask as described other radioactive materials associated S 72.48, and as updated in accordance in the Final Safety Analysis Report (as with spent fuel storage. An ISFSI which with S 72.70; updated), make changes in the is located on the site of another facility (ii) For general licensees, the Safety procedures as described in the Final licensed under this part or a facility Analysis Report for a ISFSI, MRS or Safety Analysis Report (as updated), and licensed under part 50 of this chapter spent fuel storage cask, as modified as conduct tests or experiments not and which shares common utilities and a result of changes made pursuant to described in the Final Safety Analysis services with such a facility or is S 72.48, and as updated in accordance Report (as updated), without obtaining physically connected with such other with S 72.216; and either a license amendment pursuant to facility may still be considered (iii) For certificate holders, the Safety S 72.56 (for licensees), if a change in the independent. Analysis Report for an approved cask, conditions incorporated in the license is modified by as a result of changes ma le not required, and the change, test, or

11. in S 72.9, paragraph (b) is revised Pursuant to S 72.48 and as updated in experiment does not meet any of the i

to read as follows: accordance with 572.248. criteria in paragraph (b)(2) of this (3) The ISFSI. MRS. or spent fuel section or a Certificate of Compliance $ 72.9 information collection storage cask as described in the Final (CoC) amendment pursuant to S 72.244 requirements: OMB approval. Safety Analysis Report (as updated) (for certificate holders), if a change in j means: the terms, conditions or specifications (b) The approved information (i) The systems, structures, and incorporated in the CoC is not required; collection requirements contained in components that are described in the and the change, test, or experiment does this part appear in SS 72.7,72.11,72.16, Final Safety Analysis Report as updated not meet any of the criteria in paragraph j 72.19.72.22 through 72.34,72.42,72.44, in accordance with SS 72.70, 72.216 or (b)(2) of this section. The provisions in 72.48 through 72.56,72.62,72.70 572.248, this section do not apply to changes in 1 through 72.82,72.90.72.92.72.94, (ii) The design, performance procedures when the appli able 72.98,72.100,72.102,72.104,72.108, requirements and methods of operation regulations establish more specific 72.120,72.126,72.140 through 72.176, for such systems, structures, and criteria for accomplishing such changes. 72.180 through 72.186,72.192,72.206, components required to be included or (2) A licensee shall obtain a license 72.212,72.216,72.218.72.230,72.232, described in the Final Safety Analysis amendment pursuant to 572.5ti and a j 72.234, 72.236, 72.260, 72.244. and Report (as updatec;), and certificate holder shall obtain a CoC 1 72.248. (iii) The evaluations for such systems, amendment pursuant to S 72.244. prior

12. In S 72.24, paragraph (a) is revised structures. and components required to to implementing a change, test, or l

as follows: be included in the Final Safety Analysis experiment if it would: Report (as updated) and which (1) Result in more than a minimal $ 72.24 Contents of application: Technical demonstrate that their intended increase in the probability of occurrence infonnaHon. function (s) will be accomplished. of an accident previously evaluated in (4) Procedures as describedin the either the Final Safety Analysis Report (a) A description and safety Dna1 Safety Analysis Report (as (as updated), or in evaluations assessment of the site on which the updated) means information in the performed pursuant to this section and ISFSI or MRS is to be located, with Final Safety Analysis Report (as safety analyses performed pursuant to appropriate attention to the design bases updated) regarding how structures. 59 72.56 or 72.244 after the last Final for external events. Such assessment systems, and components are operated Safety Analysis Report was updated j must contain an analysis and evaluation or controlled and information pursuant to SS 72.70,72.216 or S 72.248, 1 of the major structures, systems and describing conduct of operations. of this part, as applicable; I components of the ISFSI or MRS that (5) ReduTon in margin ofsafety (ii) Result in more than a minimal q bear on the suitability of the site when associated with any technical increase in the probability of occurrence the ISFSI or MRS is operated a' its specification means that the input of a malfunction of structures, systems, ) i design capacity. If the proposed ISFSI or assumptions, analytical methods, and components important to safety MRS is to be located on the site of a acceptance conditions. criteria and which were previously evaluated in nuclear power plant or other licensed limits of the safety analyses, presented either the Final Safety Analysis Report i l facility, the potential interactions in the Final Safety Analysis Report (as (as updated), or in evaluations between the ISFSI or MRS and such updated), that established any technical performed pursuant to this section and other facility-including shared specification requirement, are altered in safety analyses performed pursuant to ) l common utilities and services-must be a nonconservative manner. SS 72.56 or 72.244 after the last final J l cvaluated. (6) Tests or experiments not described safety analysis report was updated in the Fina1 Safety Analysis Report (as pursuant to SS 72.70,72.216 or S 72.248,

13. Section 72.48 is revised to read as updated) means any condition where of this part, as applicable; follows:

the ISFSI, MRS or spent fuel storage (iii) Result in more than a minimal cask or any of its systems, structures, or increase in the consequences of an 9 9 48 Changes, tests and experiments, components are utilized or controlled in accident previously evaluated in either (a) Definitions-As used in this a manner which is either: the Final Safety Analysis Report (as section: (i) Outside the controlling parameters updated), or in evaluations performed (1) Change means a modification, of the design bases as described in the pursuant to this section and safety l tddition or removal. Final Safety Analysis Report (as analyses performed pursuant to SS 72.56 (2) Fina1 Safety Analysis Report (as updated) or or 72.244 after the last final safety updated) means: (ii) Inconsistent with the analyses in analysis report was updated pursuant to (i) For site-specific licensees, the the Final Safety Analysis Report (as section 72.70. 72.216 or S 72.248. of this Safety Analysis Report for a ISFSI. MRS updated). part, as applicable; or spent fuel storage cask, submitted in (b)(1) A licensee or certificate holder (iv) Result in more than a minimal accordance with 5 72.24, as modified as may make changes in the ISFSI. MRS. Increase in the consequences of a i

1 / 56124 F:d:ral R: gist:r/Vol. 63, No. 203/Wtdnesday, October 21,1998/ Proposed Rules malfunction of structures, systems, and Certificate of Compliance who Commission by the licensee. This components important to safety which permanently ceases operation, any such submittal shall include the following: were previously evaluated in either the records shall be provided to the new Final Safety Analysis Report (as holder of caA Certificate of Compliance (2) A description and analysis of i updated), or in evaluations performed or to the Commission, as appropriate, in changes in procedures udn structures. I pursuant to this section and safety accordance with S 72.234(d)(3). systems, and components rf the ISFSI or analyses performed pursuant to S 72.56 (2) Annually, or at such shorter MRS, as described in the F5 \\R (as or S 72.244 after the last final safety interval as may be specified in the updated), with emphasis upon: cnalysis report was updated pursuant to license or CoC, each holder of a license S 72.70, S 7.216 or S 72.248. of this part, or cask Certificate of Compliance shall (c) The licensee shall submit revisions 4 (v Create tile possibility for a design de c i n f cl n es te ts d basis accident of a different type than experiments made by the license or rep acement-page basis'that is l any evaluated previously in either the certificate holder under paragraph (b) of 8CC mPanied by a list which identifies Final Safety Analysis Report (as this section, including a summary of the the current pages of the FSAR following updated), or in evaluations performed evaluation of each. Licensee and Page replacement. Each replacement j pursuant to this section and safety certificate holders shall submit their Page shall ine Me both a chang? analyses performed pursuant to SS 72.56 reports in accordance with 5 72.4. Any indicator fr, the ea changed (e.g., a or S 72.244 with respect to design basis report submitted by a licensee or

• " I"
  • 1. 8 accidents after the last final safety certificate holder pursuant to this adjacent to the portion actually analysis report was updated pursuant to ParagraP will be made a part of the changed) and a page change h

S 72.70, S 72.216 or S 72.248, of this part* Public record pertaining to the license identification (date of change or change licable; ts a$) Create the possibility for a r CoC. (v number or both).

14. Section 72.56 is revised to read as i

malfunction of structures, systems, and

16. In S 72.86, paragraph (b) is revised f II W5 components important tc safety with a to read as follows:

difierent result than any evaluated $ 72.56 Application for amendment of I 72'86 Criminal P'"*Iti*** previously in either the Final Safety license. Analysis Report (as updated), or in Whenever a holder of a license desires (b) The regulations in this ped 72 that evaluations performed pursuant to this to amend the license (including a are not issued under sections 161b, section and safety analyses performed change to the license onditions), an 1611, or 161o for the purposes of section pursuant to SS 72.56 or S 72.244 after the last final safety analysis report was application for an amsndment shall be 223 are as follows: SS72.1,72.2.72.3, updated pursuant to S 72.70, S 72.216 or filed with the Commission fully 72.4,72.5,72.7,72.8,72.9,72.?6,72.18, S 72.248, of this part, as applicable; describing the changes desired and the 72.20,72.22,72.24,72.26,72.28,72.32, (vii) Result in a reduction in the reasons for such changes, and following 72.34,72.40,72.46.72.56,72.58,72.60, margin of safety associated with any as far as applicable the form prescribed 72.62,72.84,72.86,72.90,72.96,72.108, technical specification (viii) Result in a f r riginal applications. 72.120,72.122,72.124,72.126,72.128, significant increase in occupational

15. In S 72.70, paregraphs (a), (b),

72.130,72.182,72.194,72.200,72.202, exposure; introductory text, and (b)(2) are revised 72.204,72.206,72.210,72.214,72.220, i (ix) Result in a significant unreviewed to read and a new paragraph (c) is added 72.230, 72.238, 72.240, 72.244, and l cnvironmental impact. to read as follows: 72.246. l (c)(1) Each licensee or certificate 5 72.70 safety analysis report updating.

17. In S 72.212, paragraph (b)(4) is holder shall maintain records of changes revised to read as follows:

in the ISFSI, MRS, or spent fuel storage (a) The design, description of planned cask and of changes in procedures it has operations, and other information $ 72.212 Conditions of generaillconse made pursuant to this section if these submitted in the Safety Analysis Report issued under 5 72.210. I changes constitute changes in the ISFSI, for an ISFSI or MRS sha!! be updated by + MRS, or spent fuel storage cask or the licensee and submitted to the (b) * *

• procedures described in the Final Safety Commission at least once every six (4) Prior to use of this general license, Analysis Report (as updated). The months after issuance of the license determine whether activities related to licensee or certificate holder shall also during final design and construction, storage of spent f set under this general maintain records of test and until preoperational testing is license involve a change in the facility experiments carried out pursuant to completed, with a Flaal Safety Analysis Technical Specifications or require a paragraph (b) of this section. These Report (FSAR) completed and submitted license amendment for the facility records shallinclude a written to the Commission at least 90 days prior pursuant to S 50.59(c)(2) of this chapter.

evaluation that provides the bases for to the planned receipt of spent fuel or Results of this determination must be the determination that the change, test, high level radioactive waste. The FSAR documented in the evaluation made in or experiment does not require a license shallinclude a final analysis and paragraph (b)(2) of this section. or CoC amendment pursuant to evaluation of the design and

18. In S 72.216, new paragraph (d) is paragraph (b)(2) of this section. The performance of structures, systems, and added to read as follows:

records of changes in the ISFSI, MRS, or components that are important to safety spent fuel storage cask and of changes taking into account any pertinent $ 72.216 Reports. In procedures and records of tests and information developed since the experiments shall be maintained until submittal of the license application. (d) The final safety analysis report spent nuclear fuel is no longer stored in (b) After the first receipt of spent fuel (FSA.%,or each approved cask used by the ISFSI, MRS or spent fuel storage or high-level radioactive waste for the general licensee shall be updated cask, and the Commission terminates storage, the FSAR shall be updated annually and submitted to the the license or CoC. For a holder of cask annually and submitted to the Commission by the generallicensee.

F Il* Frdertl Regist:r/Vol. 63. No. 203/ Wednesday. October 21,1998/ Proposed Rules 56125 The submittal shallinclude the 572.248 Safety analysis report updating. DEPARTMENT OF TRANSPORTATION following: (a) The design, description of planned (1) A description and analysis of operations, and other information Federal Aviation Administration changes in procedures or in structures. submitted in the Safety Analysis Report l systems, and components of the spent for a spent fuel storage cask shall be 14 CFR Part 39 fuel storage cask, as described in the updated by the certificate holder and FSAR (as updated), with emphasis submitted to the Commission after the [ Docket No. 98-NM-269-AD) up(on:1) Performance requirements, been approved pursuant to 5 72.238. design of the spent fuel storage cask has NN 212W64 This Final Safety Analysis Report Airworthiness Directives; McDonnell Jus ifi t on ere ru n hich such (FSAR) shall be completed and Douglas Model MD-90-30 Series trements have been established, and submitted to the Commission within 90 Airplanes r i$1) Evaluations showin8 that safety I"" days after approval of the cask design. 2 s ft i n fi nce of The FSAR shall incorporate all changes AGENCY: Federal Aviation any changes to codes, standards, and requirements contained in the CoC Administration. DOT. regulations, or regulatory guides which and the staff's safety evaluation report ACTION: Notice of proposed rulemaking the general licensee has committed to (SER) associated with approval of the (NPRM) ca meeting the requirements of which are b) e SAR shall be updated

SUMMARY

This document proposes the applicable to the design, construction, or fabrication of the spent fuel storage annually and submitted to the adoption of a new airworthiness Commission by the certificate holder.

directive (AD) that is at:plicable to )' The generallicensee shall submit This submittal shall include the certain McDonnc!! Douglas Model MD-90-30 series airplanes. This proposal f 11 win [escription and analysis ofwould require modification of the right revisions containing updated (1)A information to the Commission,in accordance with S 72.4. on a changes in procedures or in structures, and left main landing gear (MLG) replacement.page basis that is systems, and coraponents of the spent hydraulle damper assemblies or accompanied by a list which identifies fuel storage cask, as described in the replace.. ent of the MLG hydraulic the current pages of the FSAR following FSAR (as updated). with emphasis damper assemblies with modified and reidentified hydraulic damper page replacement. The general licensee up(on:1) Performance requirements, assemblies. This proposal is prompted shall also pro' Je a copy of the (11) The bases, with technical by reports indicating that, during submittal to the holder of the certificate justificati n therefor upon which such overhauls, the MLG hydraulic dampers for the cask. Each replacement page ulrements have been established, and shall include both a change indicator for rej111) Evaluations showing that safety assemblies failed or had damaged spring h ( l retainers due to insufficient material f nctions will be accomplished. thickness of the spring retainers. The vert a1 r wn in Se m rgin jacent (2) An analysis of the significance of actions specified by the proposed AD to the portion actually changed) and a any changes to codes, standards, are intended to prevent failure of the page change identification (date of regulations, or regulatory guides which hydraulic damper assemblies of the change or change number or both). Each the certificate holder has committed to MLC. which could result in vibration replacement page shall also Indicate the meeting the requirements of which are damage and collapse of the MLG. cask FSAR, including the certificate applicable to the design, construction' DATES: Comments must be received by holder's revision.' umber, upon which or fabrication of the spent fuel storage December 7,1998. the general licensee s update is based. cask'The certificate holder shall submit

19. Section 72.244 is added to read as (c)

ADDRESSES: Submit comments in f 11 ws: revisions containing updated triplicate to the Federal Aviation 972.244 Appilcation for amendment of a information to the Commission, in Administration (FAA), Transport certificate of compilance. accordance with 5 72.4, on a Airplane Directorate, ANM-ll4, Whenever a certificate holder desires replacement.page basis that is Attention: Rules Docket No. 98-NM-to amend the CoC (including a change accompanied by a list which identifies 269-AD,1601 Lind Avenue. SW.. to the terms, conditions or the current pages of the FSAR following Renton, Washington 98055-4056. specifications of the CoC), an Page replacement. The certificate holder Comments may be inspected at this application for an amendment shall be shall also provide a copy of the location between 9:00 a.m. and 3:00 i filed with the Commission fully submittal to each general licensee using P.m., Monday through Friday, except describing the changes desired and the the spent fuel storage cask. Each Federal holidays. i reasons for such changes, and following replacement page shall include both a The service information referenced in i as far as applicable the form prescribed change indicator for the area changed the proposed rule may be obtained from inal a lfcations (e.g., a bold line vertically drawn in the The Boeing Company Douglas Products for orffection 2.246 is a'dded to read as margin adjacent to the portion actuallyDivision,3855 Lakewood Boulevard, 20. follows. changed) and a page change Long Beach, California 90846, identification (date of change or change Attention: Technical Publications $ 72.246 issuance of amendment to a number or both). Business Administration Dept. Cl-L51 certificate of compilance. 'Y Dated at Rockville, Maryland, this 14th day examined at the FAA, Transport In determining whether an of October

• 1998' amendment to a CoC will be issued to Airplane Directorate,1601 Lind the applicant, the Commission will be For the Nuclear Regulatory Commission.

Avenue, SW., Renton, Washington or at guided by the considerations that j hn C. Hoyle, the FAA, Transport Airplane govern the issuance of an initial CoC. Secretary orthe Commission. Directorate, Los Angeles Aircraft

21. Section 72.248 is added to read as IFR Doc. 98-28066 Filed 10-20-98; 8 45 aml Certification Office,3960 Paramount follows:

en uwo coon rsoo-ow Boulevard. Lakewood, California.

o kB AfCg .? 't i E j 5 \\'..../ RULEMAKING ISSUE (Notation Vote) FebruaN 22.1999 SECY-99-054 FOR: The Commissioners FROM: William D. Travers Executive Director for Operations

SUBJECT:

PLANS FOR FINAL RULE - REVISIONS TO 10 CFR PARTS 50,52, AND 72: REQUIREMENTS CONCERNING CHANGES, TESTS, AND EXPERIMENTS PURPOSE: This paper (1) provides an overview of the comments received on the proposed rulemaking on 10 CFR 50.59, (2) forwards the staff's proposals to resolve several issues related to implementation of 50.59 and (3) recommends final rule language for a revision of 50.59 and related provisions in Parts 50,52, and 72. These changes affect the regulatory requirements controll'ag licensee changes, tests, and experiments for production and utilization facilities and for facilities for independent storage of spent nuclear fuel and high-level radioactive waste.

SUMMARY

The staff is revising 9 50.59 (and related sections) to clarify the criteria that determine wher, changes require evaluation by the licensee and when changes require NRC approval before they are implemented. A few key issues from the proposed rule and from the public comments on the proposed rule require Commission direction before the staff can finalize the rulemaking package. This paper discusses (1) the background of the proposed rulemaking, (2) the public comments on the proposed rulemaking, and (3) staff recommendations for the final rule based upon review of these comments in addition, this paper contains staff's recommendation conceming the question of the scope of @ 50.59 as requested by a Staff Requirements Memorandum (SRM) dated March 24,1998. CONTACT: Eileen McKenna, NRR 415-2189 ~ % Cra% -f c N % h - --~ww w~ _g

m e The Commissioners 2 BACKGROUND: Section 50.59 defines the ' conditions under which reactor licensees may make changes to their facilities or procedures, or to conduct tests or experiments without prior NRC approval. In general, such change s, tests, or experiments may be carried out unless they would involve a change to the technical specifications, or an unreviewed safety question (as defined in $ 50.59(a)(2)). Similar language exists in $ 72.48 for independent spent fuel storage installations (ISFSI) or monitored retrievable storage installations (MRS) for storage of spent nuclear fuel or high-level waste. The Commission approved a staff recommendation to initiate rulemaking in its SRM on SECY-97-205, dated March 24,1998. The Commission directed that the proposed rule aliow "rninimal" increases in probability or consequences (where minimal is greater than negligible). In this SRM, the Commission also directed staff to consider conforming changes for other parts of the regulations. The Commission also asked staff to provide (1) a recommendation conceming the scope of 10 CFR 50.59, in February 1999; (2) a status report on the effectiveness of the short-term actions (from SECY-97-205); and (3) recommendations on whether to pursue more resource-in >ensive. and high-impact long-term actions. The staff recommendation conceming the scope of 9 50.59 is discussed in this paper below. Commission papers that provide information un the short-term actions include SECY-99-001, dated January 5,1999 (updating guidance for final safety analysis reports (FSARs)) and SECY-98-224, dated September 28,1998 (on commitment management). Staff is also preparing a separate memorandum that provides the current status of interactions with the Nuclear Energy institute (NEI) conceming guidance to determine what constitutes design basis information. The staff recommendations on long-term actions to make Part 50 more risk-informed were provided in SECY-98-300, dated December 23,1998 (which was also responsive to an April 25,1997 SRM requesting an integrated approach to the requirements in Part 50 that includes clear, consistent definitions and risk considesations). In SECY-98-171, dated July 10,1998, staff forwarded a proposed rulemsiking package to the i Commission with a recommendation to issue the proposed rule for public comment. In this rulemaking, staff proposed a number of changes to $ 50.59, including the addition of definitions and reformatting, deletion of the term "unreviewed safety question," revisions to criteria to allow ) changes invoMng minimal increases in probability or consequences or creation of malfunctions ~ f a different type (but not with a different result from what was previously evaluated), to be o made without prior NRC approval. Staff also proposed an approach for" margin of safety reduction" that would focus upon the safety analyses that established the technical i specifications. In the proposed rulemaking, similar changes were proposed for those sections in Part 72 relating to change control and also to extend the change control authority to Certificate of Compliance holders (for spent fuel storage cask designs). Other conforming changes necessitated by the changes in $$ 50.59 and 72.48 were also proposed. ) in its SRM of September 25,1998, the Commission approved staff's proposal to issue a proposed rule for public comment. The Commission did not adopt staff's proposed recommendation on margin of safety and also offered other questions and issues for consideration. The Commission specified a number of topics for which public comment'should be sought in the Federal Register (FR) notice, most particularly, for a broad range of options on

m The Commissioners 3 margin of safety.- Further, individual Commissioner vote sheets were included in the FR notice so that interested parties would understand preliminary views of the Commission on these issues.. The proposed rule was published in the Federal Register (63 FR 56098; October 21, 1998) for a 60-day comment period ending December 21,1998. The Commission's SRM of September 25,1998, requested staff to complete the rule on an expedited schedule (by February 19,1999). Because of the range of views on a few important issues, such as margin of safety, staff concluded that Commission direction was needed on an approach for these issues before s'aff finalized its rule package, as discussed in a memorandum to the Commission dated December 21,1998.~ DISCUSSION: .] Fifty-nine letters commenting on the proposed rule were received. A list of the commenters is provided in Attachment 1. Further, Attachment 1 discusses and analyzes the comments, which are organized by topics as presented in the proposed rule. A summary of the major issues and staff recommendations for resolving these issues are presented herein. Commission approval of these recommendations, or selection of an attemative approach is requested so the final rule package can be prepared. In addition, the staff notes the degree of consistency of the proposed approach with the existing industry implementation guidance, NEl 96-07. The proposed rule reorganized the rule requirements, including separation of the evaluation criteria into seven separate statements. The following discussion refers to this numbering. presents the revised rule language, which has been modified in accordance with the recommendations presented herein. Additional refinements to the rule langutge may arise as staff completes the comment review and concurrence process. 1.0 MAJOR TOPICS 1.1 Probability of occurrence of an accident or malfunction of equipment important to safety previously evaluated t.1 the FSAR (as updated) is more than minimally increased (H so.se(c)(2)(i) and (c)(2)(li)) The proposed rule included language that states that a license amendment was required if - there was more than a minimal increase in the probability of an accident or malfunction of - equipment important to safety previously evaluated in the final safety analysis report (as ' updated). Several comments were offered on the guidance concerning how a minimal increase would be determined. Many commenters stated that evaluations of probability would be qualitative, and they wanted the supplementary information to indicate more explicitly that quantitative analyses are not expected. Commenters also thought that it was not clear how to determine qualitatively that there was no more than a minimal increase in probability if some discemable increase could be noted. NEl has indicated that it does not intend to modify the curront guidance in NEl 96-07 that establishes a qualitative " negligible" threshold. A few commenters wanted some quantitative guidance, particularly to allow use of probabilistic risk analyses. Some commenters suggested reliance on the process established in Regulatory

I e The Commissioners 4 Guide (RG) 1.174 for changes involving quantitative evaluations. Staff's view is that if greater use is to be made of PRA information, more fundamental changes to the rule would be necessary to provide a coherent set of requirements and that the regulatory processes established in RG.1.174 would have to be reexamined for applicability to changes being made by a licensee without NRC review (for example, criteria for preservation of sufficient defense-in-depth might be needed). Further, applicability to facilities such as nonpower reactors, reactors undergoing decommissioning, and Part 72 facilities would also need to be considered. While the rule language in Attachment 2 retains the term " minimal", the staff notes that in practice, distinctions between " negligible" and " minimal" cannot be achieved for qualitative evaluations. The staff attempted to provide more quantitative guidance, but was unable to develop a meaningful value that cc,u'd be used generically (for all accidents and malfunctions), or a means of judging when the increase would be too large, when applied to the deterministic analyses in the FSAR. The staff presently plans to make certain clarifying changes to the guidance offered in the proposed rule supplementary information for qualitative assessments to implement the rule language of " minimal" increases in probability in a manner more akin to a " negligible" standard. Existing guidance in NEl 96-07 concoming " negligible" increases will satisfy the rule requirements. The " minimal" language would allow effects to be more than negligible and yet still satisfy the "minimai" criterion in the rule. The staff also recommends that the term " probability" be changed to " frequency" for occurrence of accidents, and to " likelihood" for occurrence of malfunctions. The staff concludes that these terms provide a better representation of the attribute of concem, and also how the evaluation would be conducted. Also, as discussed under topic 1.3, the staff proposes to use the term " structures, systems and components" rather than " equipment." Resolution: As noted, the staff recommends minor changes to the rule language, as presented in. 1.2 Margin of safety as defined in the basis for any technical specification is reduced ($50.59(c)(2)(vil)) The FR notice solicited comment upon a wide range of options related to the regulatory ) treatment of margin. Staff included a number of pccsibilities snd also noted that other { proposals were welcomed. The range of options presented included deletion of the criterion, as i well as options focusing upon specified parameters. For instance, rome of the options I concemed fission product barrier response with another suboption propwing inclusion of l mitigation system capability. Staff considered a range of approaches from "no change" to these parameters, up to meeting specified limits, including a concept of " minimal" r6 ductions. In addition, staff proposed an option that would control evaluation methods used to demonstrate that the selected parameters are satisfied. Although a large number of comments were submitted, they can be grouped into a few mejor themes: those supporting the discussion in NEl 96-07 (acceptance limits), those supporting deletion of margin as a criterion, and those supporting a new proposal from NEl.

The Commissioners 5 NEl proposed to replace the existing margin of safety criterion with one that states that a change requires approval if it would result in a design basis limit directly related to integrity of fuel cladding, the reactor coolant system pressure boundary, or the containment boundary being exceeded or altered. NEl noted that this recommendation is not based on the concept of minimal changes because the fission product barrier design parameters of interest are not suited to this approach. Conservative margins were built in when the design basis limits were established, and plants routinely operate at or near these lirnits, so a " minimal" change concept has little mean;ng. In its proposal, NEl also proposed controis on evaluation methods associated with demonstrating that the design basis limits have not been exceeded for parameters directly related to fission product barrier integrity. As discussed in their comment letter of December 21,1998, NEl would define evaluation methods as including such elements as methods for reducing data, correlations, physical constants, and modeling techniques. Staff examined the NEl proposal to determine whether important design parameters would be protected through application of this criterion in conjunction with the other criteria and regulations. Staff was concemed that the language of "directly related to fission product barrier integrity" might be too narrc'v. Staff was supportive of the concept of using the design basis as the determinant of when NRC approval was needed and for control of evaluation j methods. Thus, the staff's current proposal would be a modification of that suggested by NEl that focuses upon the effectivenees of systems to protect the barriers, that is, changes would be allowed without prior NRC approval that would close the gap between current calculated values and " controlling" values, provided the barriers are not challenged. This would be ~ demonstrated by showing that the systems are still capable of performing their design functions. In developing its approach, the staff was seeking to allow flexibility to licensees, yet also to provide confidence that the effects of such changes remain within acceptable boundaries. The staff criteria is intended to broaden the NEl proposal to encompass overall plant performance, including fission product barrier response, mitigation system capability and those support systems that must function for these systems to perform their functions. The focus upon functions (including support systems) and lowest functional capabilities also provides consistency with the philosophy for establishing TS. For certain systems and structures, these capabilities are already included within the TS; this approach thus brings a degree of uniformity to all plants. The staff has developed the following as recommended rule language for when prior NRC l approval is required for a proposed change, test, or experiment. A change would require NRC approvalif the change would: (vii) Result in the design basis capability for any structure, system or component directly related to maintaining the integrity of the physical barriers intended to contain radioactmty (including mitigation systems), or any system necessary to support the functions of these SSC, being exceeded or altered. (viii) Result in :nore than a minimal change in a method of analysis described in the final safety analysis rerort (as updated) that is used to establish design basis values.

The Commissioners 6 IMPLEMENTATION These criteria would then be implemented through guidance that has the following provisions: The extent of SSCs that would need to be considered under this criterion are those whose functions are to maintain inte0rity of the physical barriers intended to contain radioactivity (that - is, for reactors, fuel clad, the RCS, the primary containment, and any others), or those used to mitigate accidents or the release of radioactivity, and those support systems that must function in order to assure the functioning of accident prevention and mitigation systems, for the range rf accidents and events that the plant is required to withstand. The design basis capability (for an SSC) is the lowest functional capability that accomplishes the required functions for all required conditions, including the range of accidents and events that the facility is required to withstand. This philosophy is consistent with the 50.2 definition of design bases, and would reflect a condition that if the design basis is not met, some other system or characteristic would be materially impacted, as for instance the fission product barriers being challenged. For purposes of this evaluation _, assessment of design basis e-N!!ty for components is intended to be limited to those components necessary for ensuring the capability of the reactor coolant pressure boundary and containment barriers. Thus, the components would include such + ems as the reactor vessel, reactor coolant pumps, reactor coolant pressure boundary piping, and containment isolation valves, which have a distinct function in preserving integrity of the barriers. Changes to other components, e.g., other system piping, pumps, supports, etc., may be evaluated in terms of their effect on system functional capability under design basis conditions. CLanges to design basis capabilities would require NRC approval. Where a design basis capability has been established in the FSAR, a change in which the design basis capability continues to be met, as demonstrated by the same analysis methodology as previously used (in the FSAR), does not require NRC approval.' For analytical methods, the staff has proposed a minimal change standard, to allow licensees to use different methods, yet prevent loss of all margin. A change in a method as a single change should be benchmarked by assuring that parameters that are acceptable in the changed method would not cause systems and structures to exceed their design basis capabilities under the method that previously had been approved by the NRC. This determination would be made by comparison to previously acceptable method (s) of evaluation. The staff intends to discuss this criterion with NEl in the near future. In implementing these criteria for NRC review, staff notes that the licensee remains responsible for dome strating that TS and other regulatory requirements continue to be met for this revised system apability as part of its safety assessment of the proposed change. As noted in previous guidance, changes are to be evaluated separately. Thus, if a licensee wishes to make changes to the facility in conjunction with changes to methodology, the above standards would apply to the individua! changes. Based on the relatively high threshold which would be established under these proposed criteria, it is likely that many changes requiring a license amendment under these criteria may 1 l

The Commissioners 7 also involve a significant hazards consideration. Thus, many license t.mendments which are necessitated by these two criteria likely will have to be noticed in the Federal Registerand an opportunity for a hearing provided prior to issuance of the license amendment; any hearing granted on these cases must be completed prior to the issuance of the amendment. Significant revision to NEl 96-07 is anticipated to explain in detail the criteria and how they would be implemented. The staff believes that the use of examples will help facilitate understanding of these criteria and interpretation of minimal changes with respect to methods. Resolution: The staff suppo ts the goals of the NEl approach, but recommends a modification of the approach offered by NEl that focuses on effectiveness of structures, systems and components to protect fission product barriers, rather than just on the barrier parameters themselves. Staff believes that an apprcach such as that described above would provide a criterion that would control system capability such that barriers are not challenged, yet allow licensees flexibility to make changes that do not prevent the systems from performing their minimum functional requirements. 1.3 Part 72 Changes and related issues Several commenters stated that the requirements in Part 72 should be made even more consistent with those of 6f 50.59 and 50.71(e). These commenters also believe that certain of the requirements of Part 72 (i.e., release limits, 72.48 evaluation criteria on occupational exposure and environmental impact, and update frequency and content requirements) are more stringent than the similar provisions in Part 50. These commenters further state that these requirements are not commensurate with the relative potential risks of the two types of facilities. Staff notes that many of these differences are in existing rule requirements and do not arise from the proposed rule changes. The staff has revised Part 72 in response to these comments ) to provide greater consistency with Part 50. A few of the recommended changes may require J renoticing because they were not within the scope of the proposed rule (e.g., removal of the occupational exposure and environmental impact tests from 6 72.48), and therefore, the staff proposes to prepare a supplemental proposed rulemaking for any such issues. J Although the bulk of the changes the staff has included in Attachment 2 would conform Part 72 to Part 50's language, staff would propose the reverse in one instance. Staff would propose the use of the term " structures, systems, and components (SSCs) important to safety" in both Parts i rather than the term " equipment important to safety" as presently in Q 50.59. Staff believes that the term "SSCs important to safety" is already common terminology and is currently reflected in Part 50's general design criteria. Also staff would not propose revising release and accident

The Commissioners 8 limits in the supplemental rulemaking, because such changes would be significantly beyond the scope of the original rulemaking on " changes, tests and experiments." Additionally, several commenters stated that the change control process allowed under Part 72 should be expanded to include transportation packages (i.e., casks) certified under 10 CFR Part 71, especially for dual-purpose casks (i.e., casks certified for both the storage and transportation of spent fuel under both Part 71 and ??). Staff notes that current intemational ' Atomic Energy Agency (IAEA) safety standards for transportation of radioactive material (i.e., ST-1) do not provide for a 6 72.48 type change control process allowing for changes to the design of a transportation package without prior approval. However, staff believes that the comment to provide for a 6 72.48 type change cc,ntrol process in Part 71 has merit - if limited to transportation packages used in the domestic shipment of spent fuel. Staff would propose to expand the scope of the suggested change to both dual-purpose casks approved under both Part 71 and 72 and to transport-only casks approved under Part 71. Consequently, this change would apply to casks used to domestically ship spent fuel, including dual purpose casks. Staff believes that such a regulation in Part 71, while departing from lAEA standard ST-1, would be acceptable for spent fuel transportation packages used in domestic commerce only. Staff also believes that Part 72 licensees that ship spent fuel, Part 72 certificate holders, and Part 71 spent-fuel certificate holders have the necessary experience to implement these potential Part 71 regulations without adversely affecting the safe transport of spent fuel. NRC staff has discussed this concept with staff from the Research and Special Programs Administration of the U.S. Department of Transportation (DOT), and DOT staff did not object to this concept. Staff will coordinate this proposed change to Part 71 with the DOT in the supplemental rulemaking descnbed above. Staff will address the question of allowing a 6 72.48 type change control process for all other types of Part 71 transportation packages as part of a different rulemaking (NMSS-C3MP-26, " Compatibility with IAEA Transportation Standards, Part 71"). Resolution: Staff recommends acceptance of the comments and proposed resolution as described above. In order to provide a final rule as soon as possible, the staff recommends that a final rule be issued for both $$ 50.59 and 72.48. Staff also recommends that simultaneous with this final rule, a supplemental notice of proposed rulemaking be issued to provide for "6 71.48" chenge authonty and to address any staff responses to comments which would require renoticing for public comment. Staff recommends that a supplemental final rule on the revisions to Parts 71, and any necessary Part 72 sections, follow within 18 months of issuance of the final rule for Parts 50,52 and 72 (see Section 2.0 for a discussion of staff proposals for the implementation schedule). Guidance on the changes to Parts 71 and 72 would be develcped in concert with the guidance on Part 50 and would be issued in accordance with the implementation schedule discussed below. As noted, other Part 71 changes would be handled as part of a different rulemaking. 1.4 Other issues in the Federal Registernotice fer the proposed rule, the Commission also specifically sought comment on other topics. For hstare:e, comment was specifically requested as to whether the scope of 6 50.59 should be revised to include information other than that "as described in the 1

1 The Commissioners 9 safety analysis report." After careful consideration, staff is not proposing any change to the scope in this rulemaking. As noted, staff has provided definitions of terms such as " facility as described...", to more clearly define those changes that require evaluation and thus allow others to be screened out without a detailed evaluation. Only a few commenters indicated interest in a redefinition of the scope, and these commenters also suggested it occur as part of a longer-term revision that might be more risk-informed with respect to evaluation criteria as well. As discussed in SECY-98-300, staff is proposing to define a risk-informed scope for use in a number of Part 50 regulations. - In this effort, applicability for g 50.59 is being examined. Therefore, the staff concludes that a separate effort to revise the scope of 6 50.59 itself is not warranted. j in addition to the topics discussea within this paper, there are some other topics that affect the rule language changes or are otherwise considered to be of Commission interest which are discussed in Attachment 3. These topics include definition of change, need for definition of accident, the evaluation criterion on increase in consequences, and reporting requirements. Other comments received are for the most part editorial or minor comments. Some will be resolved through clarifications of rule language or in implementation or inspection guidance; i others will not t e adopted. Comment resolution will continue while this pper is before the Commission for deliberation to expedite completion of the final rule package. Attachment 1 contains this information and the final resNutions of the comments will be included with the final rule package when it is submitted. i l 2.0 ENFORCEMENT AND IMPLEMENTATION STRATEGY AND SCHEDULE Staff is also interested in obtaining Commission direction conceming timing of implementation i of $$ 50.59 and 72.48 and on enforcement strategy. As noted in the comment letter from NEl, time will also be needed to revise existing industry guidance (and NRC endorsement through a Regulatory Guide). Further, guidance for Part 72 licensees (and potentially for Part 71) will need development. Staff will work with NEl and industry to deve!op specific guidance for Part i 72 during this period as well as on the revisions to guidance for reactor liceneees. Once the guidance i. complete, there will be a need for revisiens to procedures, conduct of training, and ~ other activities to facilitate implementation of the revisions to the rule. These factors would suggest a relatively long period before the rule changes become effective. On the other hand, many reactor licensees may wish to use the enhanced flexibilitv provided by the reased criteria as soon as possible. Accordingly, the staff recommends that trie Commission follow a strategy by which the existing 99 50.59 and 72.48 rules would remain in effect for an 18 month period and the revised rules would be issued and made effective during this 18 month period. The revised rules, will by their terms, replace the existing rules at the end of the 18 month period. If a licensee (or certificate holder) wishes to implement the revised rule (s) sooner than the 18 month deadline, this could be done upon written notificati6si to NRC of the effective date by which that licensee would implement the revised rule in place of the existing rule. Future development of the inspection ar.d enforcement strategy will also be coordinated with the changes occ :rring to NRC oversight and assessment processes.

l The Commissioners 10 ) During the period until the revised rules are implemented, ctaff also recommends that it continue to exercise some enforcement discretion, using the following approach for violations of 99 50.59 and 72.48:

1) The staff intends to exercise discretion to refrain from enforcement action for non-willful violations of existing $$ 50.59 or 72.48 requirements that would not be violations had the evaluations been performed using the revised rule. The staff does not plan to document such matters in inspection reports.

2) Failure to perform written evaluations or maintain required documentation would be 1

i considered Severity Level IV violations and generally treated as non-cited violations. The fallere during the implementation period to submit an amendment as required, where the NRC finds the underlying licensee action acceptable without the need for substantial review, would also be categorized at a Severity level IV (consistent with current practice for enforcement discretion in this area).

3) A failure to submit an amendment as required would be considered a Severity Level 111 violation if either a) a substantial review is needed by the NRC before it could conclude that the licensee's actions were acceptable or b) NRC would not have found the licensee's actions acceptable.

4) However, if the licensee's failure to meet the new rule appeared to be in good faith based on either a misunderstanding of the new requirements as a result of lack of guidance or insufficient time to implement changes from the old rule, discretion would be exercised under section Vil B.ti of the Enforcement Policy.

5) After the effective date for $$ 50.59 and 72.48, a failure to subrr.it a required amendment would be considered a Severity Level ill violation. l' NRC would not have j

found the changes made by the licensee or certificate holder (wnhout NRC approval) to be acceptable, the severity level could be increased to a Severity LWel 11. The staff would maintain an enforcement panel made up of NRR (and NMSS as applicable), OE, and OGC representatives for some months after publication to maintain consistency. In addition, as part of the final rulemaking package, changes will need to be made to the Enforcement Policy. CONCLUSION-Staff is seeking Commission direction conceming the recommendations contained herein, and on the (draft) final rule language presented in Attachment 2. Upon receipt of this direction, staff will then forward a final rule package (including any supplemental proposed rule for Parts 71 and 72) consistent with this guidance as expeditiously as possible.

r The Commissioners 11 RECOMMENDATIONS: 1. That the Commission approve staff's recommendations discussed above; l' 2. That the Commission allow early release of this paper to facilitate industry's interaction with the staff on these proposals and to initiate preparation of guidance. COORDINATION: The Office of the General Counsel has no legal objection to this paper. . The staff will meet with the Advisory Committee on Reactor Safeguards during its March 1999 . meeting to discuss the recommendations in this paper. '3 '-- William D. Travers Executive Director for Operations Attachments:

1. Discussion of public comments on the proposed revision to 10 CFR Parts 50,52 and 72 (63CFR 56098)

2. Recommended final rule language for 10 CFR 50.59 and related provisions

3. Other rule language changes and issues Comissioners ' completed vote sheets /coments should be provided directly to the Office of the Secretary by COB Tuesday, March 9, 1999.

Commission St.aff Office coments, if any, should be submitted to the -Commissioners NLT March 2, 1999, with an information copy to the Office of. the Secretary. If the paper is of such a nature that it requires additional review and comment, the Commissioners and the Secretariat should be apprised of when comments may be expected. DISTRIBUTION: Commissioners OGC OCAA 'OIG 1 OPA l OCA-i ACRS 1 CIO i CFO i l-EDO REGIONS SECY-I

T: ' ATTACHMENT 1: DISCUSSION OF PUBLIC COMMENTS ON THE PROPOSED REVISION TO 10 CFR PARTS 50,52 AND 72 (63 FR 56098) 1

DISCUSSION OF COMMENTS This attachment provides the initial staff analysis of the comments received in response to the FR notice published on October 21,1998 (63 FR 56098), for a proposed revision to 10 CFR 50.59, and related provisions including Part 72. - Fifty-nine responses were tabulated. As noted, one filing was a duplicate, so there are fifty-eight documents included in this analysis. A list of the submittals is included in this attachment. For purposes of analysis, each letter was reviewed to identify comment areas and topics. For the most part, comments were specifically tied to one of the numbered subsections from the notice, so this numbering system was used in the tables that follow. Those comments that could not be directly tied to one of these sections were placed at the end. A number was assigned to each sechon or paragraph of each letter that was considered as being a separate comm_ent. The tables group the comments by using a system where the fi st digit refers to the number assigned to the comment letter (see list), and the second set of numbers link to either the numbering system used by the commenter or these staff-assigned numbers, so that all comments could be accounted for, and also grouped with comments on the same topic. The Nuclear Energy Institute (letter 22) submitted a set of comments that had been circulated among its members in order to provide consolidated views. This is reflected by the 35 letters from power reactor licensees that generally endorsed these comments, sometimes with modification or additional comments. Further, submittals from three law firms, on behalf of a number of licenseees, were made. For these reasons, a precise accounting of the number of commenters making a particular comment, or agreeing with a comment is difficuit. i j i

e COMMENT LETTERS ON 63 FR 56093 Number ' Dalg. Author name Affiliatiori i 1. 11/3/98 Paul Sicard none 2. 11/3/98 Brendan Ryan. Kansas State University 3. 11/18/98 ' Kurt Schaefer A&K Nuclear Ucensing 4 12/11/98 . S. Gambhir Omaha Public Power District. 5 12/18/98 lan Rickard ABB-CE 6. 12/1'//98 Steven Toelle USEC 7. 12/17/98. Michael Croson INEEL 8. 12/18/98 J.Beasley Southem Company 9. 12/17/98 K. Singh Holtec Intemational 10. 12/18/98 James Mallay Siemens Power Corporation 11. 12/21/98 Steven Franz Morgan, Lewis and Bockius j 12. 12/18/98 Richard Phares lilinois Power l 13. 12/17/98 James O'Hanlon Virginia Power 14. 12/18/98 Sherry Bemboft Florida Power 15. 12/18/98 Kenneth Peveler Alliant Utilties 16. 12/21/98 Daniel Stenger Winston and Strawn 17. 12/17/08 Michael Kansler Entergy 18. 12/18/98 Larry Grime L.A. Grime And Associates 19. 12/18/98 Lester Slaback NIST 20. 12/18/98 Donna Alexander CP&L 21. 12/18/98 Ted Fiegenbaum North Atlantic Energy 22. 12/21/98 Anthony Pietrangeio NEl 23. 12/21/98 Malcolm Philips NUGEQ 24. 12/21/98 R. Krich Comed 25, 12/21/98 Joseph Quirk Genera' Electric 26, 12/21/98 Norman Peterson Detroit Edison l 27. 12/21/98 Paul Gaukler Shaw Pittman Potts... I 28. 12/21/98 - (SAME AS 23) 29. 12/21/98 E.D. Fuller BNFL Fuel Solutions 30. 12/21/98 G. Zinke Maine Yankee Atomic 31. 12/21/90 David Powell PSE&G l

2 32. 12/17/98 John Oddo YAEC 33. '12/17/98 Lew Myers First Energy 34. 12/xx/98 Bill Ellis none 35. 12/18/98 Robert McCredy Rochester Gas & Electric 36. 12/20/98 Lynne Goodman none 37. 12/21/98 John Fomicola GPU 38. 12/21/98-Charles Cruse Baltimore Gas & Electric 39. 12/21/98 Bradford Houston Nebraska PPD 40. 12/21/98 Al Passwater Amoren UE 41. 12/21/98 Matthew Petitclair none 42. 12/17/98 Rajiv Kundalkar Florida Power and Light 43. 12/18/98 James Levine Arizona Public Service 44. 12/18/98 Mike Tuckman Duke Energy 45. 12/21/98 H.A. Sepp Westinghouse Electric 46. 12/21/98 Martin Bowling Northeast Nuclear 47. 12/21/98 James Baumstark Consolidated Edison 48. 12/21/98 Garrett Edwards PECO 49. 12/21/98 J. Knubel NYPA 50. 12/21/98 Edward Scherer Southem Califomia Edison 51, 12/21/98 Gary Taylor SCE&G 52. 12/21/98 Michael Wadley Northem States Power 53. 12/21/98 Lance Terry Texas Utilities 54. 12/21/98 M.A. McBumett South Texas Project 55, 12/21/98 Richard Muench Wolf Creek 56. 12/29/98 Richard Olson none 57. 12/21/98 Mark Burrynski TVA 58. 12/22/98 Nathan Haskell Consumers Power 59, 12/22/98 Carl Terry Niagara Mohawk

I. l 4 i A.1 50.59(b) Applicability: The provisions of this section apply to each holder of a license authorizing operation of a production or utilization facility, including the holder of a license authorizing operation of a nuclear power reactor that has submitted the certification j of permanent cessation of operations required under 50.82(a)(1) or a reactor licensee l whose license has been permanently modified to allow possession but not operation of the facility. Commenter & Comment item Number Consolidating the existing 10 CFR 50.59 applicability 22-2,32-2,39-8 statements into one paragraph that is labeled in a new Section (b) " Applicability" l Summary: The commenters agreed with the staff's proposal. l I Resolution: Retain in final rule l l l

A.2 Form of Approval (Changes to (a) and (c); Moving Requirement to 50.90 for TS) Commenter & Comment item Number Relocate the existing requirement in 10 CFR 50.59(a) and (c) on 13-1,17-9,22-4,39-9 control of TS to 10 CFR 50.90. 39-10 Summarv: ' The commenters agreed with the staff's proposal. Resolution: Retain in final rule 2

l i A.3 Deletion of USO Term & Criteria itemization l Commenter & Comment item Number

1. USQ Term hhh.

Support deletion of the term "USQ" 1-6,13-1,17-6,20-1,22-3,32-3, 39-11

2. Breakout of Criteria a.

Support listing of seven separate criteria 17-8,22-3, 32-3 b Offers other screening criteria, e.g. impact safety of 3-14 operation, change to TS, change to facility from its description in the FSAR, etc..

3. The staff needs to address how to treat previous 13-1, 22-5 guidance and accepted practices that have used the term of "USQ."(e.g. GL91-18, Rev 1)

4. Establish a simple process to change the existing TS 17-7,22-6 that contain the term "USQ" or safety evaluation without licensees having to submit license amendments.

Summary: The commenters generally agreed with the staff's proposal. However, some commenters expressed concems that with the proposed rule language change it may inadvertently impact previous guidance and accepted practices that have used the term "USO." It may also have impact on many licensees' TS which contain "USQ." Resolution: Retain in final rule. Include text in supplementary information conceming existing guidance. Staff plans to issue inspection guidance following approval of final rule. With respect to TS changes, the staff is considering options - one approach may be to allow pen-and-ink changes to TS substituting the term " requires license amendment" for "unreviewed safety question". Suitable rule text may need to be added to speak to conflicting requirements, noting that the rule supersedes TS text. This approach was used for a final rule on section 50.4, see 51 FR 40303, dated November 6,1986. 3

B.1 Change: Change means a modification, addition, or removal. I Commenter & ) Comment Item Number Propose attemative definition for change, " Change means a 20.2(p1), supports focus modification or addition to, or removal from, the facility or on design function procedures that affects a design function, method of performing 21.2(p2) or controlling the function, or an evaluation that demonstrates 22.9 (ll.A.1, pp3-4) that intended functions will be accomplished." 24.2(p1) 27.12(p9) Believe this change needs to be made because: it will be clear 35.1(p1) that insignificant changes are screened out of the 50.59 38.3(ll.B.3,p6) process,.which will result in more effective resource allocation 39.1&2(pA1&2) by licensees and the NRC. Specifically, evaluation against the 43.1(p1) seven criteria of the proposed Section (c)(2) should not be 46.1(p1) required for changes to design details that do not impact design 52.1&3(p2) functions or metbr$s of performing or controlling design 53.1(pA1) functions. (Similar to above) Unclear what changes constitute " addition." 11.7(2.3,p5) Could imply that trivial additions (tags) or any new procedure. 38.3(ll.B.2&3,p5&6), Need to limit to significant additions. Believe Commission did specific changes not intend all additions, but language not precise, suggested. Recommend that NRC clarify that " addition" means an addition to the facilitythat either (1) introduces a new hazard that potentially could affect a safety function described in the FSAR, (2) changes the operation or response of the facility as described in the FSAR, or (3) is otherwise inconsistent with the FSAR or outside the controlling parameters of the design basis as described in the FSAR. " Additions" should be treated the same as tests and 11.8(2.3,p5), experiments. That is, a 50.59 would only be required for 38.4(ll.B.3,p6) procedures that are inconsistent with the FSAR or outside the design basis of the FSAR. Equipment removed from service, or to support maintenance, 1.9(ll.B.3,p4) should not be considered a change, and should instead be 17.16(ll.B.8,p4) controlled by tech specs or the maintenance rule (suggested 22.10 (ll.A.2, p4), adding clarification to suppl info in final rule) 38.7(ll.B.8,p8) 52.3(p2) 4 J 1

A 1 k 50.59 evaluations do not have to be performed unless the 21.2(p2) proposed change meets the definition of change and either the 22.11(ll.A.3,4,pp4) definition of facility or procedure as described in the FSAR 24.2(p1) 4 (suggested discussion should be added to Suppl into by some 27.12(p9) commenters) 38.3(ll.B.2,p6) 39.1&2(pA1&2) A change to an ' analysis method or oarameter' is only a chanae 1.7 (ll.B.1,p3) to the facility only if the method or parameter is described 17.11(ll.B.2) explicitly or implicitly in the FSAR. 39.2(maybe,pA2) 55.1(p1, notes that method term is too broad) Provide specific examples for integrated (or interdeoendent) 1.8 (ll.B.2, p3) j changes. Clarify, too narrow (comment 11.11 suggested within 11.11(2.6,p7&8) same accident analysis) 27.16(p10-11) adds i language (see below) j Interdeoendent. adopt position: " Multiple changes to the facility 27,16 (p10-11), see above or its procedures may be evaluated collectively (iA, may be as well I considered elements of a single change for purposes of review under section 50.59) if they are interrelated. Changes are considered interrelated if (1) they are interdependent, as in the case where a modification to a system or component necessitates additional changes to other systems and components (or procedures) in order for the modified system to perform its function or comply with its design or licensing basis; (2) they are proposed collectively to address a design or operational issue; or (3) they are otherwise planned as elements of a single project undertaken to restore, maintain or improve plant performance or safety." Interdeoendent: Proposed posl tion on what constitutes a single 17.15(ll.B.7,p4) change is consistent with the guidance in NEl 96-07. However, 39.3(pA2) there is no need to develop a definition in the rule. Remove discussion of interdeoendent changes, encourage 7.5(5,p4) licensees to group changes provided that net effect reduces risk or is a minimalincrease in risk. Nominal Values. NRC should provide guidance on treatment of 1.10(ll.B.4,p4), nominal values (when do they become a change?). 17.12(ll.B.4,p3) If change is made in response to issues in generic 1.13(ll.B.7,p4) communications, does this constitute a ' change' or is it already 17.14(ll.B.6,p4) previously approved by the NRC, and thus a 50.59 or amendment not required? 5

r 4 j Replacement of components with equivalent components 11.22(3.1,p10) l should only be considered a change if the replacement 53.1(pA1) ) l componeni has characteristics that are different from those i described in the FSAR. l 20 49 Ed. similar to preceding, equipment replacements that 23.1,23.4 (p2,3,4) are qualified per 50.49 should not be treated as changes under ) 50.59; e.g., do not alter underlying design bases. { l Installation and testina of Mods orior to License Amendment-11.23(3.2, p11) should be allowed provided that the mod is not implemented 12.3(p2-3) (and its installation and testing would not require an amend). 22,7 This is equivalent to drafting a procedure before its approved 44.10(p4) for use. Agree with NEl that GL91-18 approach should remain 13.2(p2) i unchanged. Therefore, to ensure that Appendix B, Criterion 16 j and 50.59 do not interfere, suggest 50.59(c)(2) be modified to read, "A licensee shall obtain an amendment to the license pursuant to Section 50.90, prior to implementing a change, test, or experiment unless the activity is in accordance with Section l' .50, Appendix B, if it would..." i To avoid a legal conflict (that exists today) between 50.59 and 38.5(ll.B.6,p8) GL91-18, a clarification needs to be made such that licensees following GL91-18 will not be in violation of 50.59. Consistent with Commissioner Diaz's comments, adding 17.10(ll.B.1,p3) definitions is not necessary and only adds confusion. As industry commented on NUREG-1606, changes to the SAR, whether to procedures or the facility, require a 50.59 (unless it is an inconsequential change), if the level of discussion within the FSAR is unaffected by the 17.11(ll.B.3,p3), proposed change, and there is no change to the results of any 38.3(ll.B.3,p6) underlying design analysis, then there is no requirement to 39.1&2(pA1&2) 1 I perform a 50.59 evaluation. Rule should clearly indicate that " changes" include " additions". 32.4(ll.B,p2) Also should be clear that changes under 50.59 (72.48) are not limited to physical changes, but include standards, procedures l or calc methods (which can potentially affect the design bases) Terms in rule need to be defined, but concemed that by making 35.1(p1) them part of the rule any subsequent interpretation would l require rulemaking. l 6 m

~. Proposed definition of change fails to recognize that there are 38.4(ll.B.3,p8) two separate changes th"t : ed to be defined. The first is the actual change to the pla ' vnich must be evalua:ed to determine if 50.59 is applicable. The second is the text or drawing change to the FSAR description of the facility, which requires a 50.59 safety evaluation. Safety evals should only be i applicable to the FSAR described facility and any text-drawing changes. All otner changes should screen out. Definition should recognize that changes are only proposed 38.6(ll.B.7,p8) changes. Thir will avoic' 'he problem with 'de facto design changes'. in GB of the FRN, use of word ' parameter'is too broad, clarify 45.1(p1) to read, "... changes to parameters that affect regulatory limits", or " effects of the parameter change." Rule should specifically address and exclude from the 50.59 48.2(pA1) process administrative changes to organizational, reporting ~ relationships, and job titles. Since the tenn desian bases does not have a consensus, its 55.1(p1) use can be misleading. The term ' removal'should be clarified to include: removal from 56.1(pA1) service, physical removal, retirement in place, discontinued availability, removal from the FSAR text or tables, and removal from FSAR figures. If change is limited to those that affect content of UFSAR, then 56.3(p1) effective scope of 50.59 will be reduced, as practiced by some licensees, who interpret 50.59 to mean that a change to anything that aDDears in the UFSAR must be evaluated. Summarv: Commenters offered several proposed clarifications and concems about the definitions. Most were directed at allowing screening of changes that did not affect functions, or of other activities that should not require 50.59 evaluations. A few commenters wanted the rule language to explicitly codify the philosophy in GL 91-18 concoming the "de facto" changes and corrective action. Resolution: The staff recommends a revision to the rule language on change that would accommodate screening. No rule changes are recommended concem ng the "de facto" changes - staff believes existing guidance is adequate. Other comments can be handled through appropriate implementation guidance. 7 I

r O B.2 Facility As Described: Facility as described in the final safety analysis report (as { updated) means: (1) The systems, structures, and components that are described in the final safety analysis report (as updated), (ii) The design, performance requirements and methods l of operation for such systems, structures and components required to be included or . l described in the final safety analysis report (as updated), and (iii) The evaluations or methods I of evaluation required to be included in the FSAR (as updated) for such SSC and which j dernonstrate that their intended function (s) will be accomplished. 1 1 Commenter & l Comment item Number 1 Delete " required to be included or"from Sfii & iii. Requirements 10.2(p1) I for FSAR are in f50.34(b) and 50.71(e) 11.10(2.5,p6) i 22.12 (ll.B.1,pp5) 27.13(p9) 39.4(pA3) 52.2(p2) Replace " required to be included or" with a reference to the 31.1(p1) definition of safety-related SSCs contained in 50.2 Delete " methods of operation"from 6 il because the 22.13 (ll.B.2,pp5) Information is captured by the definition proposed for " procedures as described" Endorse treatment of information " incorporated bv reference" 1.11(ll.B.5,p4), as in NEl 98-03. 17.13(ll.B.5,p4) 38.12(ll.E.2,p11) Commenter 38 suggests the definition of incorporated by reference be added to the rule. Limit criteria (iii) to ' plant-specific input variables and results' 3.6(3(a),p6&A-1) from the evaluations included in the FSAR. Delete third criterion (50.59(a)(2)(iii), on evaluations and 7.10(10,p6) methods because its inclusion discourages licensees from adopting new (improved) methods. Modify definition to include only "those aspects of systems, 27.12(p9) structures and components as are described in the final safety 39.4(p2&3) analysis report." As proposed by staff, any change to a SP" l would require 50.59. Need to screen out some changes. Discussion in NOPR is inconsistent in use of FSAR, sometimes 38.2(ll.B.1,p5) uses SAR, where FSAR would be appropriate. 8

A Support Chairmans position that definition of procedures (and 38.8(ll.B.9,pS&9) by extension of facility), needs clarification. Specifically, suggest: ' Facility as described in the final safety analysis report (as updated) means (1)[ sic] The FSAR description of the design, function or method of performing the function of any i system, structure or component (SSC). Limit applicability of 50.59 to design bases to FSAR-described 38.19(p11) design bases. Clarify in the rule or NRC endorsed guidance that there is no 44.1(p1) need for 50.59 evaluations for 'second tier' programs such as procurement specs, evaluation methods and other sub-tier design info docs that are controlled by App B. 'As described in the final safety analysis report (as updated)' 56.2 may narrow the scope of the regulation, in practice, because some licensees have interpreted current language to include licensing documents not specifically reference in the FSAR text. Summarv: Commenters offered ideas on other ways to phrase the requirements, especially with respect to the language of " required to be included". Resolution; The staff has accepted some of the comments conceming wording of the definition of facility. See also comments on " change"- other comments will be addressed in the statement of considerations for the final rule. 9

i B.3 FSAR (As Updated): Final safety analysis report (as updated) means the Final Safety Analysis Report (or Final Hazards Summary Report) submitted in accordance with $50.34, as amended and supplemented, and as modified as a result of changes made pursuant to 6 50.59 and 6 50.90, and, as applicable, 6 50.71(e) and (f). Commenter & Comment item Number Replace "as modified as a result of changes made pursuant to 18.2(p2) didn't propose Section 50.59 and Section 50.90, and, as applicable, Section wording, }ust simplify 50.71(e) and (f),"with, "as updatedper the requirements of 10 22.14(l1.C.1,pp5) CFR 50.7t(e)." This is consistent with NEl 98-03 39.5(pA3), proposed similarlanguage To simplify asction (c)(2), expand definition of FSAR by 18.2(p2)didn't propose including the phrase in criteria (c)(2)(i)-(vi), by adding the wording, just to simplify following, *Forpurposes ofimplementing this section, the FSAR 22.15(ll.C2-3,pp5-6) (as updated) is considered to include evaluations performed pursuant to this section and analyses performedpursuant to Section 50.90 after the last update of the final safety analysis report pursuant to Section 50.71 of this part. Agree with NEl 22,15 comment, except delete phrase, 39.5(pA3&4)

• evaluations pursuant to this section and' Delete from $(c)(2)(i-iv), "...or evaluations performedpursuant 39.5(p/ 3) to this section and analyses performed pursuant to Section 50.90 after the last final safety analysis report was updated pursuant to Section 50.71 of this part."

Summary: Commenters offered rephrasing of the definition to reduce complexity in the rule text. i Resolution: The staff recommendation is to revise the final rule along the lines proposed by NEl to simplify the criteria statements by including the language about other evaluations as part of the definition of FSAR (as updated). i 10

s A C.1 Procedures: Procedures as described in the final safety analysis report (as updated) means information in the final safety analysis report (as updated) regarding how structures, systems, and components are operated and controlled (including assumed operator actions and response times) and information describing the conduct of operations. Commenter & Comment item Number Delete " conduct of operations." 11.9 (2.4,p5-6), except asked for clarification Basis: while required to be in FSAR, admin procedures are 22.16(ll.D,pp6-7) under AppB (&50.54), criteria in 9(c)(2) don't work, changes 27.14(p10) don't meet proposed change (see comments 22.11-12) 52.4(pA2) definition. The proposed definition or procedures is welcome and will 1.14(ll.C.1,p4) reduce utility burden by not requiring 50.59 reviews of support procedures. Add criteria of,"The analytical methods of the evaluations 3.6(3(b),p6&A-2) required to be included in the FSAR (as updated) for such SSC and which demonstrate that their intended function (s) will be accomplished". Proposed new definition of ' procedures as described' is more 32.5(ll.C,p3) definitive than the current rule and appropriately emphasizes operator actions and response times, which can affect critical factors in the safety analysis. Share Chairman's concem that definition of procedures is 38.9(ll.C.1,p9) flawed (p56115). Suggest following definition:" Procedures as described in the final safety analysis report (as updated) means the FSAR description of the operation and control (including assumed operator actions and response times), of any system, structure, or component (SSC) and information on conduct of operations. Discuss and clarify that 'information on conduct of operations' 48.3(pA1) excludes procedures of an administrative nature. Terminology of " assumed operator actions" is too vague, 55.1(p1) l should only include explicitly described (in the FSAR) operator actions es changes under 50.59 Summary: Several commenters offered clarifications of the definitions. The major objection l was to the phrase " conduct of operations", which many thought was too broad and would encompass administrative procedures not suitable for 50.59 review. l 11

Resolution: The staff recommends clarifications to the definition, including deletion of the words " conduct of operations" 12 9

Q l C.2 Applicability Re. Procedures: The provisions in this section do not apply to changes in procedures when the applicable regulations establish more specific criteria for accomplishing such changes. Commenter & 1 Comment item Number 1 Support the change 17-17,22-8,32-5,39-46,57-4 Expand the scope to include modifications to the plant as well as to 8 procedures. Clarify how 10 CFR 50.59 applies to TRM COLR, ODCM, PTLR, 57-4 FPR and Safeguards Contingency Plan 1-44 Summary: There are 5 comments commenting on this item; they all agreed with the staff's proposed change. However, some commenters suggested the staff go further: (1) to expand the scope to include modifications to *he plants, not only " procedures" and (2) to clarify how 10 CFR 50.59 applies to some s facial documents, such as Technical Requirements Manual, Core Operating Limitu Report, Offsite Dose Calculation Manual, Pressure and Temperature Limits Report, Fire Protection Report and Safeguards Contingency Plan. As noted under topic N, the change process for topical reports was also raised by commenters. Resolution: The staff plans to accept the wording revision proposed by NEl. Other comments will be addressed in the SOC or guidance as applicable. i 13

D. Test and Experiments: Tests or experiments not described in the final safety analysis report (as updated) means any condition where the reactor or any of its systems, structures or components are utilized or controlled in a manner which is either: (1) Outside the controlling parameters of the design bases as described in the final safety analysis report (as updated) or (ii) Inconsistent with the analyses in the final safety analysis report (as updated). Commenter & Comment item Number Definition acceptable 1-15,32-6 Definition should be in guidance or use NEl 96-07 definition 17-18 Recommends the use of the term " activity" rather than " condition" 22-18 to be r~1sistent with the proposed rule language and to avoid confusion with discovered " conditions" covered by GL 91-18. 50.59 should define tests and experiments and address how their 38-10 control as procedures should be controlled Term " reactor or any of its SSCs" could be misleading. May want 39-7 to reference 50.2 definition of design bases Summary: Of the 58 responses received, there were 15 responses that did not address this item,35 responses that indicated agreement with the comment from NEl and 5 independent comments. The majority of the comments supported the proposed wording with minor clarifications. The suggestion to revise the section to address procedures that control tests and experiments should not be necessary as the proposed wording appears to be well understood. The comment from NEl had no objection to the proposed wording except to recommend the use of the term " condition" rather than "ae'ivity" in the final rule so as to avoid confusion with discovered " conditions" which are by the guidance in Generic Letter 91-18, Revision 1. Two responses agreed with the proposed wording as written. One response recommended placing the definition in the guidance or using the definition from NEl 96-07. One response felt that because " tests and experiments" are controlled by procedures, Section ll.D should be revised to address how the control of these actnrities as procedures is controlled. See also comments under topic P about use of the term " design basis". Resolution: The staff proposes to retain the definition with some clarifications, such as referring to "actmty" rather than " condition." + 14

I ~ l E.1 Final Safety Analysis Report - Definition: Final safety analysis report (as updated) means the Final Safety Analysis Report (or Final Hazards Summary Report) submitted in accordance with 6 50.34, as amended and supplemented, and as modified as a result of changes made pursuant to 9 50.59 and @ 50.90, and, as applicable,9 50.71(e) and (f). (See B.3) Commenter & Comment item Number Should be made clear that TS and their Bases are part of the 38.11(II.E.1,p9&10) FSAR. In some cases, the TS, have detail not in the FSAR, such as applicable modes, that may be relevant to 50.59. Define the FSAR such that it recognizes it is updated so that 38.12(II.E.3 p11) each time FSAR is stated, it is not necessary to add the term (as updated). Adds no value. Propose following definition for FSAR in 50.59: "The set of 44.2(p1&2). licensing basis documents used to support issuance of a plant operating license. These documents include, but are not limited to, the Facility Operating License, the NRC Safety Evaluation Report, the UFSAR, Selected Licensee Commitments, the Technical Specifications, and other l licensing documents.' Summary: Only a few comments were received on this subitem, generally seeking clarification. Resolution: No changes to rule text planned. While staff agrees with last comment with respect to implementation, the definition is considered too broad to be included in the rule. i 1 15

l E.2 Safety Analysis Report and Pending Changes:...as previously evaluated i in the final safety analysis report (as updated), or in evaluations performed pursuant to this I section and safety analyses performed pursuant to section 50.90 after the last final safety analysis report was updated pursuant to section 50.71 of this part. Commenter & Comment item Number A change could be made (50.59 or 50.90) that would 1.21(ll.G.2,p11) significantly lower probability or consequences from that - 4.1(1,p1) described in the FSAR. Norrnally, the FSAR would not be updated to reflect this. Literal compliance with proposed wording would make the new evaluation become the acceptance criteria for all future 50.59 evaluations Could also require that all previous 50.59/50.90 evaluations be reviewed to ensure most conservative result is reflected in the FSAR. It is appropriate for proposed rule to require evaluation to 32.7(ll.E, p3) include changes already made for which the UFSAR update has not been submitted, to ensure the evaluation is based on most up to date information. The phrase "and safety analyses pursuant to Secs 72.56 or 7.6 (would also apply to 72.244" (corresponding part wording is "and safety analyses Part 50) performed pursuant to Sec 50.90]" used in six of the license amendment criteria makes it appear that a licensee could prepare a license amendment pursuant to 70.56 or 72.244 [50.90] and use the associateo safety analysis for subsequent changes permitted by 72.48 [50.59] before the amendment is approved.] Summarv: Commenters had concems on two aspects - whether the rule would require systematic review of all evaluations since the last update, and whether the rule language suggests that licensees update the FSAR or use as the baseline for evaluation amendment requests that are still pending. 16

Resolution: See also topic B.3. The staff still concludes that it is appropriate for licensees to consider changes made subsequent to the last update to ensure that evaluations reflect current configuration of the facility. The process that a licensee would follow to confirm this is not being prescribed. If the changes were such that the FSAR information (description, analysis) is still accurate, subsequent changes could be evaluated with respect to the FSAR(as updated) description - otherwise, there should be a planned FSAR update awaiting submittal that should be used as the basis for review. With respect to the last issue, this can be addressed in guidance or the supplementary information. Staff believes that this is not generally misunderstood and notes that existing language in 50.71(e) that refers to evaluations in support of requested amendments could be similarly misinterpreted. However, staff also notes that other rule changes in 50.59, such as in (c)(1) make more explicit the need to obtain approval before implementation. Staff also plans to revise " requested" amendments to instead say " approved amendments" in 50.71(e) i i 17 i

F. Probability or Consequences No More Than Minimally Increased: Result in more than a minimal increase in... previously evaluated in either the final safety analysis report... Commenter & Comment Item Number Comments are discussed in sections G.1 and G.2 l t 18

r ,y r i j G.1 - Guidance on "More Than Minimal" - Probability l Commenter & Comment item Number L Unclear whether the guidance on a change in accident classification 22-20,1-19, l is intended as the definition of a more than minimal increase in 17-19,18-3, l-probability of an accident or as an example of such an increase. 38-16 NRC should provide guidance on whether a change in probability class for an event analyzed in the SAR constitutes merely an increase in probabiliyy or the change in probability class results in a new accident. NRC should recognize that changes within the frequency classification do not constitute an increase in probability. An increase in probability would be realized only if the event moved into a more frequent classification. Does not agree with the proposed wording conceming the concept of 2-2 minimalincrease.' " Minimal"is itself an arbitrary expression. The 29-3 NRC uses an oversimplified depiction of safety analysis in trying to define " minimal increase". However, safety limits involve many parametens. Modify the discussion on probability of equipment malfunction in 22-21 Section ll.G of the NOPR to "The probability of malfunction of 39-13 equipment important to safety previously evaluated in the FSAR (as 43-2 updated)is na T,aia ?,an.7,lnl,T.allylac,cae;Jnotincreasedif design requirements are met." Agrees with the statement "the probability of malfunction... is no 18-5 more than minimally increased if ' design basis' assumptions and requirements are still satisfied [i.e.~......]," but recommends deletion of the reference to " procurement requirements as a design basis ) assumption or equipment" because procurement requirements ) normally are in excess of the design bases requirements and procurement requirements do not establish the design basis; the design basis helps to determine the procurement requirements. 1 i i l 19 i

The evaluation of a change against the probability of malfunction 22-21 criterion should be performed consistently. Modify it to "-7he 20-3 1 C~,;;,;;l l a L:lle;ee mal me prot tlllt, alaia,%ae:lan lo a; ore men 22-22 n;l,ila;all, lne.ea ee lla a;;;l;lluee aide ao lll,eli ao ea..:,,,g aiadoo 18-4 knntree6ced.-The determination of whether the probability of 31-3 malfunction is introducedis more than minimallyincreased should be 11-S made erther at a the component level, er consistent with the failure 38-17' modes and effects analyses in the FSAR, :alang lala aea~n: olagle

llere a aip laae, aad me l;;;l af et,aaga bo,ag aiade."

The guidance in the final rule should expressly reflect Commissioner 27-3,27-4 McGaffigan's comments, and expressly state that, although the current NEl guidance certainly satisfies the rule, the rule affords greater flexibility than that provided for by the current NEl guidance. Recommends that the NRC develop quantitative standards for " minimal increase" and define " minimal" in the context of probability. Quantitative methods (e.g., PRA) could be used to better define 22-23 when a change involves more than a " negligible"- but less than a 32-9 " minimal" - increase in probability and thus may be implemented 1-18 without obtaining a license amendment. 38-15 27-4 NRC needs to provide additional guidance on using risk insights, if ' 39-13 there is an increase in probability of undesired outcome. Agrees with the proposed guidance which states that several 11-4, 32-8 provisions in NEl 96-07 satisfy the proposed standard on minimal. However, the NRC should clarify that NEl 96-07 does not represent the outer bounds of what is acceptable under the proposed rule because NEl 96-07 was developed to implement the current rule, which is more restrictive than the proposed rule. The above positions would not require the term " minimal increases in 17-19 probability" to be defined. If the above approaches are not acceptable, the NRC should endorse the existing industry positions presented in NEl 96-07. Agrees with NRC's conclusion and the proposed language that 27-2 j " minimal increase" should not require prior NRC approval. 36-2 NRC should provide clarifications to the proposed rule to clarify and better define what is meant by minimal. 20 1

i in defining minimal increase in probability or consequences, the SOC 19-2 should explicitly acknowledge that in the case of non-power reactors, these risks are already minimal so that the primary thrust of a 50.59 analysis in this instance is mm in terms of consistency with SAR than quantitative assessment. This adds burden to both NRC and licensees. The NRC concludes that licensee can treat changes in external 39-14 hazard design requirements as potentially affecting equipment probability rather than as accident probability. - This should be reflected in guidance. Agrees with the proposed rule change to allow a minimal increase in 1-17 probability, and corresponds to NSAC-125 and NEl 96-07 Summarv: Most comments agree with NEl comments and/or NEl 96-07. Specifically, these comments address: need a description / definition of " minimal increase" evaluations of changes against the probability of malfunction criterion should be performed at a level consistent with existing analyses in the FSAR clarify position if the resulting probability (even though increased) still satisfies the event frequency classification provided in FSAR, whether the change is considered to be more than a minimalincrease Resolution: The staff was not able to provide a definitive ctandard for " minimal" that is more than " negligible" as judged in a qualitative evaluation. Quantitative criteria that might use PRA would be best developed in a different context, such as RG 1.174, rather than for the i existing criteria of changes in probability of FSAR accidents and malfunctions. The proposed guidance offered in the FR notice will be modified to respond to the comments, and will either be part of a RG or included in industry guidance. i l i 21 l

G.2 Guidance on "More Than Minimal"- Consequences Commenter & - Comment item Number Clearly state that the term " consequences" refers to radiological dose. 22 24,20-4, 38-14,39-15, 43-3,44-4,59-2 Prefers the third option in NOPR because it is easier to implement and 22-24,20-5, it is self limiting. With following comments: 33-1,11-6, 13-3, 38-21, Acceptance guidelines - NOPR approach is too restrictive, illogical, and 43-3; 51-1, i lacks regulatory standing. Recommends changes allowed by the 52-6, 38-22, lesser of the following: 1-22,59-3, e 10% of the margin to 10 CFR limits, or 39-17,39-18 e the applicable acceptance guidelines (if any). NRC should endorse the existing guidance of NEl 96-07 which sets the 1-20 limit as the value accepted by the NRC in the SER, which are generally tied to the acceptance limits in the NRC SRP. e provide examples on why it is more preferable to determine increases in consequences based upon the SRP and/or SER acceptance limits instead of the values documented in the SAR e Tying " increase in consequences" to the values reported in the SAR rather than to the acceptance limits quoted in the SER will penalize those plants which maintain a greater level of detail in the SAR. To maintain the original NRC acceptance bases, plants should be 3-3 categorized as Pre-SRP and Post-SRP plants. For Post-SRP plants, the SRP acceptance dose criteria per accident type, used as the basis for their original NRC acceptance, should be used as threshold values for determining a minimalincrease in consequences. For Pre-SRP plants, the graduated percentage table in FR 56105 should be acceptable as long as the limits are based on full Part 100 guideline values. Acceptance limits should be based on SER rather than those reported 17-20 in SAR.. 27-7 Agrees with the second Option which addresses the concem of 17-22 cumulative affect. 22

I 1 3 NRC should address the case of plants that have lowered dose due to 1 21,4-1,17-23 one changes and subsequently increased dose due to a later change. The concem is that the minimal increase definition might require review for the second change while it might not had the first change not been f made. For the example given in the second paragraph under'" Consequences 17-24 of an acci.ient or malfunction"in Section ll.G (a bounding analysis that is'still satisfied), the example has no increase in consequences because the new analysis result remains bounded by the previous analysis result. Supports percentage guidance of 20% versus 10% as proposed by the 18-6,27-6 draft guidance. 39-19,44-5 Does not agree with tlse NRC's position on " controlling" inputs, 38-19 assumptions, and methodologies associated with dose calculations, not described in the FSAR, as rigidly as those described in the FSAR. This goes beyond the scope and intent of 50.59 rule. Commenters believe that changes to methodology related to - 1-36 (p.16),17-31 consequence calculations that have been generically accepted by NRC (such as ICRP dose conversion factors or SRP assumptions conceming fission product scrubbing) can be used by licensees without approval. Consequences of " malfunctions" and consequences of " accidents" 18-9,38-20 should be combined into one, (not discussed separately as existed in the proposed rule). Consequences are based on analyzed DBAs. The graduated approach seems to capture the spectrum of potential 32-9 licensee scenarios while not impacting the basis for acceptability. This option provides the maximum flexibility by referencing to the limit. Agrees with option 3, which allows for minimal changes up to a certain 39-16 percentage of remaining margin. Guidance should expand upon the application to GDC 19 considerations, and whether it should be included in the scope. Recommends that the new rule be applied appropriately to the 59-2 radiological consequences of accident and not to the radiological consequences associated with normal operations or arJicipated operational occurrences. i 23

m Summarv: Most comments agree with NEl's comments in that, a clear statement should be included that states the term " consequences" refers to radiological dose. In addition, most comments received endorses NEl's comments on Option 3 with the acceptance limits to which minimal is applied being regulatory values (Part 100, GDC 19) or not to exceed any applicable SRP guidelines.- Also, comments supported proposal of 10% of the margin to Part 100 limits (with a few comments proposing 20%). Some commenters would prefer use of the limit alone, without a " minimal increase" standard. Resolution: The staff proposal on consequences is presented in the Commission Supplementary information and guidance will address other issues raised by the comments 24

H.1 Accident - Definition: An initiating event or combination of events and/or ' conditions that could occur from equipment failure, human error, natural or manmade hazards which challenges the integrity of one or more fission product barriers (fuel, reactor coolant Nam, release of radionuclides (confinement / containment), required to be analyzea a d/or accounted for by the Commission and addressed in the licensee's safety analysis report. j i Commenter & i Comment item Number l No need to change the definition of " accident" that exists in guidance 11-13 such as NEl 96-07 Accidents should be limited to the bounding " design basis accidents" 17-25 Definition of the term " accident" should be in the guidance for 22-19,33-3 implementation of 50.59 and not in the final rule. The definition used by industry since 1989 is part of NSAC-125 and currently in NEl 96-07. Commenter concurs with NEl and espouses the definition of accident 25-1 used in Reg Guide 1.70. 25.4 Suggests definition of an accident to include DBAs, AOOs, and special 39-21 events that are analyzed to demonstrate safety 39-22 Proposed wording vague, suggests using the definition in 50.49 and 33-3 NEl 96-07 Definition of DBE reasonable, can be more specific by referring to 1-24 accidents analyzed in the SAR, including AOOs and extemal events which result in accidents analyzed (also could treat extemal events as malfunctions). Definition of accidents tied to SAR Chap.15 events is very different 1-25,17-26 from CDF used in PRA Dele a " required to be analyzed or accounted for by the Commission" 44-8 fron (he definition i Definition of event should be "a combination of postriated challenges 44-8 and failure events against which plants are designed to ensure adequate and safe plant response" The proposed wording is too convoluted to be applied consistently. 3-3 Propose using "new failure mode with a different result to safety items, new limiting AOO, or seouence of events resulting la a rad release above current operating limit in App-l or section 20" 25

Adding phrase " design basis accident" to the three criteria referring to 32-10 accidents is adequate. Adding a definition unnecessary Add " credible" to definition of accident 44 7 Summarv: Of the 58 responses received,11 responses did not address this item,35 responses indicated agreement with the comment from NEl, and 11 responses gave independent comments. The response from NEl recommended that the term " accident" should not be defined in the rule but should be in the guidance for implementation of 50.59. NEl also stated that the definition of " accident " used by industry since 1989 is part of NSAC-125 and is currently in NEl 96-07. Only two responses agreed with the definition as written. Almost all responses felt that the NRC definition tended to expand the scope of an " accident of a different type." Several comments recommended criteria such as," creates the possibility of a new limiting AOO (transient), or creates a new sequence of events that can result in a radiological release (via a normal pathway) above a currsnt operating, Section 50 App. I or Sechon 20 limit." Resolution: Staff recommendation is to provide guidance, either in RG or industry guidance document on understanding of accident - no rule language changes (beyond "is created") are recommended. 26

O' O. l H.2 Design Basis Accident of a Different Type (in Criteria): Create a possibility for a design basis accident of a different type than any previously evaluated in either the final safety analysis report (as updated), or in evaluations performed pursuant to this secUon and safety analyses performed pursuant to section 50.90 with respect to design basis accidents after the last final safety analysis report was updated pursuant to section 50.71 of this part.- Commenter & Comment item Number For an event to be classified as a design bases " accident" 3-1, 3-4 it must have nadiological dose consequences and require plant design change as corrective action En6orses proposed use of DBA in the criteria for accident 11-14 of a different type Commenters concur with NEl in general but the phrase 3-4,25-1 " accident of a different type" should be defined in the rule. 25-4 Commenter emphasizes that the change needs to result in a new failure mode, new release path, or has a new sequence of events that results in significant cladding failure i Agrees with the proposed wording and emphasizes that 27-11 the accidents should be " credible" Adding phrase " design basis accident" to the criteria 32-10 referring to accidents is adequate. Adding a definition unnecessary There should be a list of types and examples of accidents 38-24 of a different type For an accident to be of a different type it must result in a 3-1 now or greater fission release path than originally J considered or result in a new fission product barrier failure j mode. Suggest using "would this be included if the FSAR was being written today."

10. Concemed that a slightly different initiator that leads to 36-4 the same DBA would be considered a new accident Commenter believes revised language of "with a different 38-25 result"should also be used here 27

i 1 Do not'use " Design Basis Accident" as this is a severely 39-20 limited definition for some older plants 39-23 44-6 ) { Summarv-Of the 57 responses received,12 responses did not address this item,34 responses indicated agreement with the comment from NEl,9 responses gave independent comments. Only a few responses indicated that use of the term " design basis accident" was acceptable as written. The remaining independent responses indicated that the term " design basis accident" would not be understood consistently by licensees and that the term should be defined in the guidance. Most of these comments favored making it clear that the term " accident of a different type" referred to design basis types of accidents and gave criteria to be used to define this term. As an example, GE emphasized that "an accident of a different type means an accident that results in a new fission product release path, results in a new fission product barrier failure mode, or creates a new sequence of events that results in significant fuel cladding failures." Resolution: The staff recommendation is to include discussion in guidance but not to include the term " design basis" in the criterion on accident of a different type. y i h 28

F-8 '. t. I. Malfunction with a Different Result: Create a possibility for a malfunction of equipment important to safety with a different result than any previously evaluated in either the final safety analysis report (es updated), or in evaluations performed pursuant to this - section and safety analyses performed pursuant to section 50.90 after the last final safety analysis report was updated pursuant to section 50.71 of this part. Commenter & Comment item Number Distinction between accident probability and failure rate of 2-3 safety equipment is unnecessary and counterproductive Malfunctions of equipment should be considered different if the 3-2 new failure mode results in a different outcome than previously considered NEl supports the change to " Create the possibility for"; use of 22-46 the phrase "important to safety";and change to " malfunctions with a different result." Agrees with proposed wording 32-11,39-24 NRC definition of a malfunction is too broad, NEl-96-07 is 38-26 narrower, A different malfunction exists only if result as described in FSAR is different regardless of cause e.g. air versus a motor operated valve Adding the term "of equipment important to safety" is 38-27 inappropriate & should not be pursued. Suggests "If a possibility for a malfunction of a different type with a different result, of FSAR-described equipment, than any evaluated previously in the FSAR is created." This evaluation is part of the design change evaluation and 38-26 should not be part of the evaluation for need of an amendment. 38-27 If a design evaluation determines a change from FSAR is effected ttuto a 50.59 evaluation is required Summary: Commenters generally agreed with the proposed rule change. Some had concems about interpretations on the level (that is, subcomponent, component or system) at which malfunctions need to be considered. As noted in comments on Part 72 (topic M), some commenters seek greater commonality in terms, equipment important to safety vs. SSC important to safety. 29

Resolution: The staff recommends proceeding with the language as offered in the proposed rule - other issues can be addressed in the guidance. Staff will retain SSC ITS in Part 72 as this term is defined and modify 50.59 to conform. Consideration of changes to definitions of ITS is part of SECY-98-300. 1 I 30 I

.i j ~, J. Margin of Safety. Several Options were offered for comment; also, the notice invited commenters to offer other proposals for NRC consideration. Commenter & Comment item Number

1. Ten commenters specifically stated that they strongly 1-27,11-1,17-28,18-7,22-oppose option 1 (control inputs to analyses) as being too 17,27-8,36-7,38-28,39-27, restrictive, making inputs equivalent to TS requirements.

46-2. (3-10) (Others would seem to agree by virtue of endorsing NEl comments). One agreed that this was best approach if NRC allowed compensating changes such that the validity of TS LCO or SL is maintained.

2. Fifteen commenters favor option 2 (delete margin as 1-32,7-7,9-2,10-1,11-2,12-criterion). Basis given is that other criteria (including the TS 1,14-1,17-29,18-7,31-2,32,

and rules) are sufficient. A few commenters said not 12,33-4,38 29,48-10 acceptable to delete, as this might leave gaps which might (3-11,25-2) lead NRC to redefine probability or consequence criteria, or 26* that there may be non-accident events invoMng malfunctions of equipment 'not important to safety" not covered (e.g., generator load rejection). One thought the NEl proposal would " collapse" to deletion of margin since the TS include all the parameters covered by the NEl proposal for particular plants 3, Option 3(A) variations (Results of analyses, specific 1-28,3-12,17-30 parameters) - many commenters had issues with the options as outlined in the notice, either that the parameters selected were not appropriate, or that there would be uncertainty about which parameters involve margins. Altemative proposals were offered. One commenter stated there was a need to clarify which 1-31 safety analyses are covered - e.g., for ventilation or support systems performance vs. ECCS or other systems NEl proposed to replace the margin of safety criterion with a 22-17,27-9 criterion that requires NRC review for a change that would: result in a design basis limit directly related to the integrity of fuel cladding, RCS pressure boundary, or containment boundary being exceeded or altered. Commenters noted that some fission product barriers are 3 12,22-17,25-5 covered by other requirements, e.g., PCT is covered by 50.46 31

The parameters affected should only be those directly 1-28,7-30,11-2,22 17 related to Fission product barriers. This cr on should only apply where there are clearly 1 30;3-9,22-17 defined "oesign basis limits" One commenter stated that changes involving mitigation 11-1 systems were covered by the other evaluation criteria and thus did not need to be part of a " margin" criterion One commenter wanted clarification in the soc that changes 23-to equipment qualification (including accident profiles) are not reductions ir. margin if 50.49 still satisfied. 1

4. Amount of Reduction allowed without review - notice offered range of options from no net change up to not exceeding limits j

Several comments stated that reductms in margin would 1 29,3-13,18-7,36-2 ] only occur from the design basis limits (or other terms) without restriction to minimal reduction in the difference between the calculated value and the limit, as suggested in i st. 3e of the options. Some commenters preferred the terminology in 96-07 of 3-13,25-2,44-9 (NRC limit) reductions being measured from " licensed acceptance limits", One commenter would clarify that these are the limits approved by NRC and would modify NEl words to read "a prescribed NRC acceptance or design code limit is exceeded or altered". (These commenters also favored increases up to these limits without a " minimal" concept). Minimal reductions in margin from the limits should be 11 24 allowed - to extent of precision of analysis One commenter believes that approval should only be 1-2 required if the limits would be exceeded, but that a change in the amount of " margin" to the limit might be established as a reporting criterion, as is done in 50.46 for PCT.

5. Evaluation Methods

a. Some commenters stated that methods should not be 1-36,17-31,36-8,38-22,39-controlled by 50.59 because the limits are conservative.

37 These commenters stated that they should be allowed to use methods approved by NRC through SRP or other process without need for 50.59 or NRC approval. Allow licensees' design control QA to govem. 32 )

7 .-( 1

b. A few commenters stated that different methods should be 11 25,22-17 reviewed / approved by NRC or meet applicable guidelines or standards; OR produce results that are consistent with licensing basis methods; OR changes to methods should be evaluated under 50.59 as a separate change.

NEl states that input assumptions can be adjusted, but must be reviewed as separate changes 1

6. Other Comments

a. Two commenters proposed that there be attemate criteria 36-6,46 for decommissioning reactors (fuel removed) - one states that fission product barriers not the issue, but would add environmentalimpact. Another suggested limiting the scope to systems related to spent fuel pool cooling or radiological waste.

b. Part 72 parameters for " margin" should be those with 17-36, 22-31 potential to increase prob. or amount of offsite releases (containment of fuel: subitems-temperature, pressure)

e. A few commenters said that as part of the final rule, the 1-43,27-10 staff should state that basis for any TS is limited to bases section. In contrast, another commenter would modify the definition of SAR to include the TS and their bases, and then the " bases for any TS" are in the SAR, and the other criteria are enough.

f. The discussion on margin could be used to provide 1-33 guidance on NSHC "significant" reduction in margin Summary:

NEl proposed attemative of meeting design basis limits directly related to fission product barriers. Several commenters favored deletion of the concept instead. Many expressed second preferences, that is, they would support NEl's approach if deletion was not accepted or the reverse. Some commenters thought that evaluation methods should not be controlled by 50.59, others agreed with NEl proposal that methods must be either reviewed and approved by NRC or otherwise meet applicable standards. Resolution: The staff proposal is discussed in the Commission paper. Guidance will be developed to ensure consistent implementation. 33

b. A few commenters stated that different methods should be 11-25,22-17 reviewed / approved by NRC or meet applicable guidelines or standards; OR produce results that are consistent with q

licensing basis methods; OR changes to methods should be evaluated under 50.59 as a separate change. NEl states that input assumptions can be adjusted, but must be reviewed as separate changes

6. Other Comments

a. Two commenters proposed that there be attemate criteria 36-6, 46-3 for decommissioning reactors (fuel removed) - one states that fission product barriers not the issue, but would add i

environmental impact. Another suggested limiting the scope to systems related to spent fuel pool cooling or radiological waste.

b. Part 72 parameters for " margin' should be those with 17-36,22-31 poter:tial to increase prob. or amount of offsite releases (containment of fuel: subitems-temperature, pressure)

e. A few commenters said that as part of the final rule, the 1-43,27-10 staff should state that basis for any TS is limited to bases section. In contrast, another commenter would modify the definition of SAR to include the TS and their bases, and then the " bases for any TS" are in the SAR, and the other criteria are enough,

f. The discussion on margin could be used to provide 1 33 guidance on NSHC "significant" reduction in margin Summary:

J NEl proposed altemative of meeting design basis limits directly related to fission product barriers. Several commenters favored deletion of the concept instead. Many expressed second preferences, that is, they would support NEl's approach if deletion was not accepted or the reverse. Some commenters thought that evaluation methods should not be controlled by 50.59, others agreed with NEl proposal that rnsthods must be either reviewed and approved by NRC or otherwise meet applicable,tandards. Resolution: The staff recommends acceptance of the NEl proposal. Guidance will be developed to ensure consistent implementation. 33

e 4 I K. Safety Evaluation Commenter & 3 Comment. Item Number Support removal of the term " safety evaluation"in favor of 1-37,17-32,22-5,39-38 simply" evaluation" Summarv There are 4 commenters commenting on this item; they all agreed with the staff's p.oposed change. Resolution: Retain in final rule - sea also topic A.3 regarding changes to TS which refer to " safety evaluations" 34

I L. Reporting and Record Keeping - Update requirements (effects of changes) Commenter & Comment item Number There should be no change in the requiraments for summarizing 1-38 individual 50.59 evaluations associated with the rule change Proposss no changes to 50.71(e) because rhanges are captured by the 17-3,20-6 existing requirements of 50.71(e) and that using NEl 96-07 guidance, 22-26-a changes in probability of equipment malfunction or accident probat.ility 22-26-b are not quantifiable, such that 50.59 evaluation criteria is met only if 52-9 there is no discemible change in probability. 32-8 Disagree with any change in 50.71(e) - including the net effect of 18-8, 21-1, 35-2, increases in probability and consequences adds burden on licensees 36-5,39-47, 44-6,48-1,51-2, 4-2,38-23, 38-31,39-15 Disagree with additional requirements because: 43-5

5. The provision for increasing consequences by a minimal amount is 57 3 self-limiting.

1-23

6. Any changes to these parameters (sufficiently important, they should 33-2 be captured in FSAR) would require corresponding changes to the FSAR, which would be 4eported" in required FSAR updates, No discussion on how to implement on this additional reporting 48-1 requirement. The industry should be given an opportunity to work with 51-2 the NRC to address the implementation concems.

Agrees with the proposed language for 50.59(d)(3) clarifying that 22-25 records of changes in the facility must be retained throughout any 17-34 license rerswal term. The proposed additional reporting requirements should be the subject 57-3 of a careful cost benefit analysis by the staff. The staff proposes to require that effects of changes be reflected in the UFSAR including new analysis performed at the Commission's request. This requirement should be explicitly identified in subsequent Commission requests for analysis and factored into future 50.109 determinations. 35

e 6 I Summarv-The majority of comments are against any additional reporting requirements and any change to 50.71(e), and endorse NEl 96-07 guidance. The basic arguments are: the provision for increasing consequences by a minimal amount is self-limiting; and that any changes to the parameters (important enough to be captured in FSAR) would require corresponding changes to the FSAR, which would be " reported" in required FSAR updates. any changes to 50.71(e) and additional reporting requirements could add burden on licensees. Resolution: The staff accepts the comments about reporting of cumulative effects. Minor wording changes would still be proposed for 50.71(e) for consistent terminology - see also i comments on Part 72 (topic M). l 36

i M:=Wift372 Commenter & Comment item NW1ber

1. Misc. Sections (72.3,.9,.24,.56,.86,.212)

a. 72.56 is not clear if it applies to site-specific licensees, 17.ll.M.12; 22.3.13 generallicensees, or both

b. The requirements of 72.48 (e.g., records) should also 22.3.7b be applied to general licensees performing 72.212 evaluations

c. The NRC should create provisions for emergency and 22.3.15 exigency processing of license amendments as allowed by 50.91(a)(5) and (6)in Part 72

2. 72.48 (Parallel to items A and K above) - Structure

a. Limit the scope of 72.48 reviews to important to safety 7.2 SSCs vs all SSCs described in the SAR

b. 72.48 can be simplified by changing the definition of 7.8 SAR and not referring to the "FSAR as updated"

c. Eliminate occupational exposure and environmental 11.2.10c,17.ll.M.6; 22.3.5; tests from (b)(2) to conform to 50.59. One commenter 29.3b; 40.2.3, 36.6 suggested that an environmental criterion may be appropriate for decommissioning reactors in 50.59, instead of other criteria such margin.

d. The risk from casks is much less than from reactors; 17.ll.M.1; 22.3.a however, many of the proposed requirements are more restrictive than Part 50

e. The environmental impact test should be retained for 48.2.4a site-specificlicensees

f. Certificate holders cannot perform an environmental 48.2.4b assessment test because they do not have an EIS to evaluate changes against

g. Generallicensees should evaluate any environmental 48.2.4c impacts against the reactor facility EIS under 50.59 not 72.48

3. 72.48 (Parallel to items B, C, D above) - Scope of Definitions

a. The term FSAR is confusing given that no PSAR exists 7.1a 37

Ul ', t 1 s s.

b. 72.48 proces. should evaluate changes made after the 7.1 b ISFSI license is issued but before the FSAR is submitted per 72.70

c. switch the order of paras (a)(2) and (a)(3).

7.3

d. Discussions of intdependent changes should be 7.5 eliminated.from 72.48, even if NRC retains it in 50.59

e. Use " equipment important to safety"instead of SSCs 17.ll.M.7; 22.3.6 l

(i.e. proposes to conform terminology with 50.59) l

f. The phrase " required to be included" should be deleted 29.1 from 72.48(a)(3)(ii) and (iii) (see also topic B re 50.59) l

g. Delete "an ISFSI or MRS" from the definition of FSAR 48.2.1 i

for a GL because the F3AR only includes the cask.

h. Clarify the wording in paragraph (a)(2)(iii) on NRC prior 48.2.2 j

approval. Sample language provided. (See also topic E.3)

4. 72.48 (Parallel to item E above) - Criteria Reference as FSAR Plus Other Evaluations

a. Eliminate para (a)(3)(iii)" evaluations"

'7.10

5. 72.48 (parallel to itemo F and G above)- More than Minimalincrease l

a. Require the linkage of changes with minimalincreases 7.6

b. "more than minimal"is subjective. Provide regulatory 29.2 guidance on this issue. (See also topic G.1) i

c. The phrase "more than minimal" should be used instead 29.3a of "significant" for occupational exposure and environmentalimpact tests

6. 72.48 (parallel to items H and I above) - Accident of a Different Type

a. Add "significant" to para (b)(2)(v) and (b)(2)(vi) or 7.9

" minimal increase in risk"

7. 72.48 (parallel to item J above)- Margin of Safety

a. Delete Margin of Safety 7.7,11.2.11a; 48.2.5

b. Any parameters used in margin of safety should include 22.3.2a only those with the potential to increase the probability or consequences of an offsite release (e.g., fuel and cladding temperature, cask temperature or intemal pressure) 38 o

s

c. Release / accident limits for Part 50 should also be used 22.3.2b for Part 72

8. 72.48 (Parallel to item L above)- Records and Reports

a. Reports sPNid be submitted at the same frequency as 11.2.10b,17.ll.M.11; 50.59 (24 months) 22.3.12;29.4

9. 72.70 SAR Updating Specific Licensees

a. _ Clarify the format for SAR updates before the FSAR is 7.1 c issued.

b. Requires more info than 50.71(e) does (i.e., proposes to 11.2.10d,17.ll.M.5, conform to 50.71(e))

17.ll.M.9e; 22.3.4

c. the change from "contain all the changes necessary..."

17.ll.M.2; 22.3.1 to " describe the effects of all the changes necessary..." is excessively burdensome and was not properly accounted for in the backfit and paperwork reduction analyses

d. Use the 24 month update frequency of 50.71 17.ll.M.9a; 22.3.9a e The requirement to update the SAR every 6 months 17.ll.M.9b; 22.3.9b before fuel is loaded is overly restrictive.

f. FSAR submittal 90 days before loading may not allow 17.ll.M.9c; 22.3.9c time for inclusion of 72.48 changes found during pre op testing.

g. Does the preload SAR requirement apply to general 17.ll.M.9d; 22.3.9d licensees

h. The 6 month cutoff date in 50.71(e) for updating the 11.2.10e,17.ll.M.10; FSAR should be included in 72.70 22.3.10 I

1. If no 72.48 changes occur in a year, a letter stating no 22.3.11; 32.ll.M.1 changes were made to the FSAR is adequate - see 50.71(c)(2)

J. Clarify that this section only applies to site-specific 48.2.6 licensees

10. 72.216 SAR Updating - General Licensee i

a. Requires more info than 50.71(e) does (i.e., conform to 11.2.10d,17.ll.M.5; 22.3.4; 50.71(e))

48.2.7 }

b. The impact of this requirement has not been 17.ll.M.8a; 22.3.7a addressed in the paperwork reduction, backfit or reg analyzes 39

o . c 4 . c. An implementation schedule for this section should be 17.ll.M.8b, 22.3.8 provided 4

d. Use the 24 month Jate frequency of 50.71 17.ll.M.9a

e. The 6 month cutoff date in 50.71(e) for updating the 11.2.10e,17.ll.M.10

) FSAR should be included

f. Guidance on timeliness of reviewing 72.48 changes 17.ll.M.13a; 22.3.14 sent by the GL to the certificate holder should be provided.-

g. Site-specific licensees should also be informed of GL 17.ll.M.13b or CoC holder 72.48 changes

h. If no 72.48 changes occur in a year, a letter stating no 22.3.11; 32.ll.M.1 changes were made to the FSAR is adequate - see 50.71(e)(2)

1. The provision on replacement pages should apply to 48.2.8 generic FSAR changes only.

J. Instead of sending FSAR changes to the CoC holder 48.2.9 send the summary of 72.48 changes. Also require this within 30 days, not the annually

k.. Revise the wording on FSAR revision numbers, it is 48.2.10 confusing 1

11. 72.244 through 72.248 - SAR and Amendments for Certificate Holders

a. Requires more info than 50.71(e) does (i.e., proposes 11.2.10d,17.ll.M.5; 22.3.4 to conform to 50.71(e))

b. Clarify that the updated FSAR need not be limited to the 11.2.11b most current design

c. Use the 24 month update frequency of 50.71 17.ll.M.9a; 29.5 l

e. The 6 month cutoff date in 50.71(e) for updating the 11.2.10e,17.ll.M.10 FSAR should be included

f. Guidance on timeliness of reviewing 72.48 changes 17.ll.M.13a; 22.3.14 l

sent by the certificate holder to the GLs should be l provided. i.

g. Site-specific licensees should also be informed of GL 17.ll.M.13b I

or CoC holder 72.48 changes 40 1

{ l

h. the change from "contain all the changes necessary 22.3.1

... to " describe the effects of all the changes necessary ... is excessively burdensome and was not properly accounted for in the backfit and paperwork reduction analyses

1. If no 72.48 changes occur in a year, a letter stating no 22.3.11; 32.ll.M.1 changes were made to the FSAR is adequate - see 50.71(e)(2)

J. Instead of sending FSAR changes to the GL send the 48.2.9 summary of 72.48 changes. Also require this within 30 days, not the annually Summary: Comments relate to following areas: -clarification of requirements relative to the three types of entities (site-specific licensees, general licensees and certificate holders - consistency of the proposed requirements between 50.59 and 72.48 (and other provisions such as for updating requirements) - consistency of existing requirements in 72.48 with comparable requirements in Part 50, and commenters views that Part 72 is more restrictive even though the risks are less. Resolution: Staff intends to provide ar;y necessary clarifications in the rule language or supplementary information. In the Commission paper, the staff has made a recommendation on how to proceed with existing requirements and consistency issues. Staff notes that some of the requirements in Part 72 are more restrictive in certain respects (e.g. release limits) because other Part 50 requirements were not imposed (offsite emergency planning). 41 j

o N. Other Request for Comment issues Commenter & Comment item Number

1. Scope l.

a. Include vendor topical reports (or develop parallel process).

1-12,17-13

b. NEl proposals on scope could allow reduction of some 1-10 defense-in-depth requirements. Reliance solely on analytical bases is not robust or resilient approach.

l

c. Agree with NEl recommendation for follow-on rulemaking to 5-2,22-27,50-2 determine appropriato, risk-informed scope.

d. USAR is good choice for scope - any decision to increase or 52 <

decrease scope should heavily weigh the practicality of implementing and enforcing any new screening criteria.

e. Could limit scope of required evalaations by designating 7-1 which parts of the SAR are subject to 72.48 (or50.59)- would allow information to remain in SAR and not require evaluations of progrt natic material

f. Comrn nter suggests that for decommissioning reactors, 46-3 scope of rule could be limited to changes that affect SSC related to spent fuel pool cooling and radiological waste.

2. Backfit issues

a. NRC underestimates the impact rule change will have on 1-41 NRC licensing reviews.

b. NRC underestimates the cost to utilities of r titional 1-42 submittals to NRC.

c. Even prospective application of the rule may require a more 16-2 detailed backfitting analysis.

d. NRC has not adequately addressed backfit burdens for Part 17-30,22-30 72 licensees 42 l

Summarv and aooroach to resolution: No summary is provided because of the range of topics. Comments will be considered in different ways - for example, scope issues will be examined in contemplated risk-informed changes to Part 50. Backfit issues will be considered during preparation of final regulatory analysis for final rule (staff notes that analysis for Part 72, although not ready at time of SECY-98-171, was included in the published documents for review). i 43

.? I O. Implementation Comments Commenter & Comment - Item Number

1. Guidance

a. NRC and NEl should work together to provide examples 1-4,17-5 that do and do not meet the evaluation criteria,

b. Provide examples of changes for which it is appropriate 1-8 or inappropriate to consider as integrated changes.

c. Provide examples of cases where activities normally 1-9 viewed as maintenance would require 50.59 evaluation.

d. Provide detailed guidance on treatment of nominal 1-10,17-12 values contained in SAR.

e. Provide clear and specific examples for " margin of 1-34 safety" issue.

f. Commenter provides checklist for guidance document.

3-14

g. NRC should endorse industry guidance via RG prior to 5-3, 22-45, 38-1,52-11 effective date of amended rule. Hold workshop to run test cases.

h. Update NUHEG-1606 with Section ll of supplementary 7-4 information or endorse NEl 96-07

1. Provide guidance that clarifies methods for 19-1 implementation appropriate to non-power reactors.

J. NRC needs to either update or supersede (listed) 38-32 guidance documents to the industry to ensure consistent guidance remains.

k. Revision of the rule not required, just issue RG, one 1-1,2-1,17-1 l

commen er su0 gests that NRC just endorse NEl 96-07. Another commenter suggests revising rule to match NEl 96-07.

l. Publish guidance concurrent with rule for format 39-10 l

and content of license amendments when 50.59(c)(2) not met e.g.- should proposed FSAR change be included, how should updating be conducted while pending)

2. Timing of implementation of rule i

i

p. NRC should define implementation period to allow 1-3,17-4,57-2 utilities to revise their 50.59 processes (and changes to NEl 96-07)

b. Rule changes should expressly be limited to prospective 16-1 application

c. Ensure that final rule is within bounds of proposed rule or 16-4, 32-1 provide opportunity for public comment on any portions of final rule that have substantially changed from proposed rule.

3. Enforcement

a. Staff should not issue NOVs for violations of existing rule 22-29,39-48, 54-1 language that will be changed under proposed rule

b. Only take enforcement during interim rulemaking period 17-3 for deviations from NEl 96-07

c. " Grandfather policy should be applied to past 22-47,39-48 evaluations done in good faith using industry guidance unless willful violation Summarv Several comments were submitted that suitable guidance was needed to support the final rule, both as industry implementation guidance (endorsed by NRC), and inspection guidance.

Resolution: The staff agrees that guidance is needed and has provided a recommended implementation and enforcement strategy in the Commission paper. I 45 A

4 P.. Other issues Commenter & Comment item Number

1. SIMPLER PROCESS: Create a more streamlined 1-5,22-28,16-3,27-1 process than license amendments for changes that don't meet 50.59 evaluation criteria but which would not otherwise require NRC approval. License amendment process for changes not affecting TS or license is not necessary.

2. RISK INFORMED REQUIREMENTS

a. Proposes that a reasonable approach to risk-1-40 informed 50.59 would use CDF and LERF as well as risk insights for improving deterministic criteria.

b. Additional, longer-term rulemaking should address 17-2,55-2 risk-informed changes

c. Differences in acceptance criteria used for Chapter 17-26 15 analyses and PRA's should be understood and considered in determining acceptance criteria or defining " accident" in any risk-informed rule

d. Risk-informed approach to 50.59 should consider 17-31 (1) some role for determining acceptability of changes based on CDF or LERF, (2) risk insights for improving the deterministic evaluation criteria that would have to remain a part of 50.59 to address non-severe accident impact.

e. Ensure that risk-informed 50.59 does not become 17-31, added regulatorylayer.

f. Eliminate the requirement that licensees 27-5 independently assess the impact of a change in the facility on the probability and conse 'uences of a malfunction of equipment important to safety in those circumstances where a licensee has incorporated the possibility of equipment malfunction in a probabilistic assessment of the probability and consequences of the i

accidents that the malfunction would affect.

3. OTHER DEFINITIONS 46

7

a. NRC should define terms "important to s.ifety" and 3-5,38-18,52-7,57-1

" design basis" particularly with respect to eq Jipment for which probabilities and consequences of ma. functions have previously been evaluated in the FSAR. One commenter suggested substituting " safety related" for important to safety.

b. Define " design bases" in terms that are not subject 18-20,55-1 to varying interpretations.

4. CHANGES TO OTHER RULES

a. Consider 50.59-like process for Part 71 5-4,22-32,29-1

b. Modify 72.48 to allow changes in a dual-purpose 11-15,32-14 cask without prior NRC approval under Part 71 and Part 72 (transportation and storage)

c. Revise 76.68 concurrently with 50.59 6-1

d. Clarify acceptance limits of 10 CFR 51.52 re bumup 1-35 assumptions for transport of spent fuel and clarify if this is subject to 50.59.

e. Incorporate all substantive provisions (e.g.,

11-16,25-3 definitions)in proposed revisions to 50.59 into ABWR design certification rule. Summary and Resolution: No summary is provided because of the variety of comments. Several of the areas raised by these comments are considered as outside the scope of the proposed rule. Comments will be forwarded to staff responsible for the areas mentioned, and will be considered in future staff actions. See also recommendations in Commission paper. 47

= N I ATTACHMENT 2: RECOMMENDED (DRAFT) FINAL RULE LANGUAGE FOR 10 CFR 50.59 AND RELATED PROVISIONS 1 i

9 e i PART 50 - DOMESTIC LICENSING OF PRODUCTION AND UTILIZATION FACILITIES

1. The authority citation for Part 50 continues to read as follows:

AUTHORITY: Secs. 102,103,104,105,161,182,183,186,189,68 Stat. 936,937,938, 948,953,954,955,956, as amended, sec. 234, 83 Stat. 1244, as amended (42 U.S.C. 2132, 2133, 2134, 2135, 2201, 2232, 2233, 2236, 2239, 2282); secs. 201, as amended, 202, 206, 88 Stat.1242, as amended, 1244,1246 (42 U.S.C. 5841, 5842, 5846). Section 50.7 also issued under Pub. L. 95-601, sec.10, 92 Stat. 2951 (42 U.S.C. 5851). Section 50.10 also issued under secs. 101,185,68 Stat. 955 as amended (42 U.S.C. 2131, 2235), sec.102, Pub. L. 91-190,83 Stat. 853 (42 U.S.C. 4332). Sections 50.13, and 50.54(dd), and 50.103 also issued under sec.108,68 Stat. 939, as amended (42 U.S.C. 2138). Sections 50.23, 50.35, 50.55, and 50.56 also issued under sec.185, 68 Stat. 955 (42 U.S.C. 2235). Sections 50.33a,50.55a and Appendix Q also issued under sec.102, Pub. L. 91-190, 83 Stat. 853 (42 U.S.C. 4332). Sections 50.34 and 50.54 also issued under sec. 204, 88 Stat.1245 (42 U.S.C. 5844). Section 50.37 also issued under E.O. 12829,3 CFR 1993 Comp., P. 570; E.O. 12958, Sections 50.58, 50.91, and 50.92 also issued under Pub. L. 97-415, 96 Stat. 2073 (42 U.S.C. 2239). Section 50.78 also issued under sec.122,68 Stat. 939 (42 U.S.C. 2152). Sections 50.80 - 50.81 also issued under sec.184,68 Stat. 954, as amended (42 U.S.C. 2234). Appendix F also issued under sec.187,68 Stat. 955 (42 U.S.C 2237).

2. Section 50.59 is revised to read as follows:

$ 50.59 Changes, tests and experiments. (a) Definitions for the purposes of this section: (1) Change means a modification or addition to, or removal from, the facility or procedures that affects a design function, method of performing or controlling the function, or an evaluation that demonstrates that intended functions will be accomplished. (2) Facility as described in the final safety analysis report (as updated) means: (i) The structures, systems, and components (SSC) that are described in the finai safety analysis report (FSAR) (as updated), (ii) The design and performance requirements for such SSCs described in the FSAR (as updated), and (iii) The evaluations or methods of evaluation included in the FSAR (as updated) for such SSCs which demonstrate that their intended function (s) will be accomplished. 1 l

D (3) Final Safety Analysis Report (as updated) means the Final Safety Analysis Report (or Final Hazards Summary Report) submitted in accordance with $ 50.34, as amended and supplemented, and as updated per the requirements of $ 50.71(e) or $ 50.71(f), as applicable. (4) Procedures as described in the final safety analysis report (as updated) means those procedures that contain information described in the final safety analysis report (as updated) regarding how structures, systems, and components are operated and controlled (including assumed operator actions and response times). (5) Tests or experiments not described in the final safety analysis report (as updated) means any actnnty where any structure, system, or component is utilized or controlled in a manner which is either: (i) Outside the reference bounds of the design bases as described in the final safety analysis report (as updated) or (ii) inconsistent with the analyses or descriptions in the final safety analysis report (as updated). (b) Applicability. This section applies to each nolder of a license authorizing operation of a production or utilization facility, including the holder of a license authorizing operation of a nuclear power reactor that has submitted the certification of permanent cessation of operations required under $ 50.82(a)(1) or a reactor licensee whose license has been amended to allow possession but not operation of the faciftty. (c)(1) A licensee may make changes in the facility as described in the final safety analysis report (as updated), make changes in the procedures as described in the final safety analysis report (as updated), and conduct tests or experiments not described in the final safety analysis report (as updated) without obtaining a license amendment pursuant to 6 50.90 only if: (i) A change to the technical specifications incorporated in the license is not required, and 2

J V 6 (ii) The change, test or experiment does not meet any of the criteria in paragraph (c)(2) of this section. (2) A licensee shall obtain a license amendment pursuant to 9 50.90 prior to implementing a change, test, or experiment if the change, test, or experiment would: (i) Result in more than a minimal increase in the frequency of occurrence of an accident previously evaluated in the final safety analysis report (as updated); (ii) Result in more than a minimal increase in the likelihood of occurrence of a malfunction of a structure, system, or component (SSC) important to safety previously evaluated j in the final safety analysis report (as updated); (iii) Result in more than a minimal increase in the consequences of an accident previously evaluated in the final safety analysis report (as updated); (iv) Result in more than a minimal increase in the consequences of a malfunction of an SSC important to safety previously evaluated in the final safety analysis report (as updated); (v) Create a possibility for an accident of a different type than any previously evaluated in the final safety analysis report (as updated); (vi) Create a possibility for a malfunction of an SSC important to safety with a different result than any previously evaluated in the final safety analysis report (as updated); (vii) Result in the design basis capability for any SSC directly related to maintaining the integrity of the physical barriers intended to contain radioactivity (including mitigation systems), or any system necessary to support the functions of these SSC, being exceeded or altered; or (viii) Result in more than a minimal change in a method of analysis described in the final safety analysis report (as updated) that is used to establish design basis values. (3) In implementing this paragraph, the FSAR (as updated) is considered to include evaluations performed pursuant to this section and analyses performed pursuant to $50.90 after the last update of the final safety analysis report pursuant to 9 50.71 of this part. (4) The provisions in this section do not apply to changes in the plant or procedures when the applicable regulations establish more specific criteria for accomplishing such changes. 3

s b (d)(1) The licensee shall maintain records of changes in the facility, of changes in procedures, and of tests and experiments made pursuant to paragraph (c) of this section. These records must include a written evaluation which provides the bases for the determination that the change, test or experiment does not require a license amendment pursuant to paragraph (c)(2) of this section. (2) The licensee shall submit, as specified in $ 50.4, a report containing a brief description of any changes, tests, and experiments, including a summary of the evaluation of each. A report must be submitted at intervals not to exceed 24 months. (3) The records of changes in the facility must be maintained until the termination of a license issued pursuant to this part or the termination of a license issued pursuant to 10 CFR part 54, whichever is later. Records of changes in procedures and records of tests and experiments must be ma:ntained for a period of five years.

3. In 9 50.66, introductory paragraph (b), paragraphs (b)(4), (c)(2), (c)(2)(i),

(c)(2)(ii), and (c)(3)(iii) are revised to read as follows: 9 50.66 Requirements for thermal annealing of the reactor pressure vessel. (b) Thermal Annealing Report. The Thermal Annealing Report must include: a Thermal l Annealing Operating Plan; a Requalification Inspection and Test Program; a Fracture Toughness Recovery and Reembrittlement Trend Assurance Program; and Identification of Changes Requiring a License Amendment (1) * (4) Identification of Changes Requiring a License Amendment. Any changes to the facility as described in the final safety analysis report (as updated) which requires a license amendment pursuant to 9 50.59(c)(2) of this part, and any changes to the technical specifications, which are necessary to either conduct the thermal annealing or to operate the nuclear power reactor following the annealing must be identified. The section shall demonstrate 4

O w that the Commission's requirements continue to be complied with, and that there is reasonable assurance of adequate protection to the public health and safety following the changes. (c) (2) If the thermal annealing was completed but the annealing was not performed in accordance with the Thermal Annealing Operating Plan and the Requalification Inspection and Test Program, the licensee shall submit a summary of lack of compliance with the Thermal Annealing Operating Plan and the Requalification inspection and Test Program and a justification for subsequent operation to the Director, Office of Nuclear Reactor Regulation. Any changes to the facility as described in the final safety analysis report (as updated) which are attributable to the noncompliances and which require a license amendment pursuant to 9 50.59(c)(2) and any changes to the technical specifications, shall also be identified. (i) If no changes requiring a license amendment pursuant to 9 60.59(c)(2) or changes to Technical Specifications are identified, the licensee may restart its reactor after the requirements of paragraph (f)(2) of this section have been met. (ii) If any changes requiring a license amendment pursuant to 9 50.59(c)(2) or changes to the Technical Specifications are identified, the licensee may not restart its reactor until approval is obtained from the Director, Office of Nuclear Reactor Regulation and the requirements of paragraph (f)(2) of this section have been met. (3) * (iii) If the partial annealing was not performed in accordance with the Thermal Annealing Operating Plan and the Requalification inspection and Test Program, the licensee shall submit a summary of lack of compliance with the Thermal Annealing Operating Plan aixt the Requalification inspection and Test Program and a justification for subsequent operation to the Director, Office of Nuclear Reactor Regulation. Any changes to the facility as described in the final safety analysis report (as updated) which are attributable to the noncompliances and which require a license amendment pursuant to 9 50.59(c)(2) and any changes to the technical specdications which are required as a result of the noncompliances, shall also be identified. (A) If no changes requiring a license amendment pursuant to 9 50.59(c)(2) or changes to technical specifications are identified, the licensee may restart its reactor after the requirements of paragraph (f)(2) of this section have been met. 5 i

4 (B) If any changes requiring a license amendment pursuant to 9 50.59(c)(2) or changes to technical specifications are identified, the licensee may not restart its reactor until approval is obtained from the Director, Office of Nuclear Reactor Regulation and the requirements of paragraph (f)(2) of this section have been met.

4. In f 50.71 paragraph (e)is revised to read as follows:

$50.71 Maintenance of records, making of reports. (e) Each person licensed to operate a nuclear power reactor pursuant to the provisions of 5 50.21 or 5 50.22 of this part shall update periodically, as provided in paragraphs (e)(3) ard (4) of this section, the final safety analysis report (FSAR) originally submitted as part of the application for the operating license, to assure that the information included in the report contains the latest information developed. This submittal shall contain all the changes necessary to reflect information and analyses submitted to the Commission by the licensee or prepared by the licensee pursuant to Commission requirement since the submission of the original FSAR, or as appropnate the last update to the FSAR under this section. The submittal must include the effects' of: all changes made in the facility or procedures as described in the FSAR; all safety analyses and evaluations performed by the licermee either in support of approved license amendments, or in support of conclusions that changes did not require a license amendment in accordance with 9 50.59(c)(2) of this part; and all analyses of new safety issues performed by or on behalf of the licensee at Commission request. The updated information shall be appropriately located within the update to the FSAR. (1)* ' Effects of changes includes appropriate revisions of descriptions in the FSAR such that the FSAR (as updated) is complete and accurate." 6

i ~

5. Section 50.90 is revised to read as follows: [same as proposed rule)

. $ 50.90 Application for Amendment of license or construction permit. Whenever a holder of a license or construction permit desires to amend the license (including the Technical Specifications incorporated into the license) or permit, application.for an amendment must be filed with the Commission, as specified in $ 50.4, fully describing the changes desired, and following as far as applicable, the form prescribed for original applications. PART 52 - EARLY SITE PERMITS, STANDARD DESIGN CERTIFICATIONS; AND COMBINED LICENSES FOR NUCLEAR POWER PLANTS

6. The authority citation for Part 52 continues to read as follows:

AUTHORITY: Secs. 103,104,161,182,183,186,189, 68 Stat. 936, 948, 953, 954, j 955,956, as amended, sec. 234,83 Stat.1244, as amended (42 U.S.C. 2133,2201,2232, 2233,2236,2239,2282); secs. 201,202,206,88 Stat.1242,1244,1246, as amended (42 U.S.C. 5841, 5842, 5546).

7. Appendix A to Part 52 is amended by revising Section Vill.B, paragraphs 5.a,b,d, and Section X.A.3 as follows:

Appendix A - Design Certification Rule for the U.S. Advanced Boiling Water Reactor Vill. Processes for Changes and Departures B. Tier 2 information

5.

• 7

s

a. An applicant or licensee who references this appendix may depart from Tier 2 information, without prior NRC approval, unless the proposed departure involves a change to or departure from Tier 1 information, Tier 2* information, or the technical specifications, or otherwise requires a license amendment as defined in paragraphs B.5.b and B.S.c of this section. When evaluating the proposed departure, an applicant or licensee shall consider all matters described in L a plant-specific DCD.

b. A proposed departure from Tier 2, other than one affecting resolution of a severe accident issue identified in the plant-specific DCD, requires a license amendment if it would-(1) Result in more than a minimal increase in the frequency of occurrence of an accident previously evaluated in the plant-specific DCD; (2) Result in more than a minimalincrease in the likelihood of occurrence of a malfunction of a structure, system, or component (SSC) important to safety previously evaluated in the plant-specrfic DCD; (3) Result in more than a minimalincrease in the consequences of an accident previously evaluated in the plant-specific DCD; (4) Result in more than a minimalincrease in the consequences of a malfunction of a SSC important to safety previously evaluated in the plant-specific DCD; (5) Create a possibility for an accident of a different type than any evaluated previously in the plant-specific DCD; 4

(6) Create a possibility for a malfunction of an SSC important to safety with a different result than any evaluated previously in the plant-specific DCD; (7) Result in the design basis capability for any SSC directly related to maintaining the integrity of the physical barriers intended to contain radioactivity (including mitigation systems), or any system necessary to support the functions of these SSC, being exceeded or altered; or (8) Result in more than a minimal change in a method of analysis described in the plant- ) specific DCD that is used to establish design basis values.

d. If a departure requires a license amendment pursuant to paragraphs B.S.b or B.5.c of this section, it is govemed by 10 CFR 50.90.

X. Records andReporting 8

s-1 i A. Records.

3. An' applicant or licensee who references this appendix shall prepare and maintain written evaluations which provide the bases for the determinations required by Section Vill of this appendix. These evaluations rnust be retained throughout the period of application and for the term of the license (including any period of renewal).

8. Appendix B to Part 52 is amended by revising Section Vill.B, paragraphs 5.a,b,d, and Section X.A.3 to read as follows:

Appendix B - Design Certification Rule for the system 80+ Design VIII. Processes for Changes and Departures B. Tier 2 information. 4

a. An applicant or licensee who references this appendix may depart from Ter 2 information, without prior NRC approval, unless the proposed departure involves a change to or i

departure from Tier 1 information, Tier 2* Information, or the technical specifications, or otherwise requires a license amendment as defined in paragraphs B.5.b and B.S.c of this section. When evaluating the proposed departure, an applicant or licensee shall consider all 4 matters described in the plant-specific DCD.

b. A proposed departure from Tier 2, other than one affecting resolution of a severe accident issue identified in the plant-specific DCD, requires a license amendment if it would-(1) Result in more than a minimal increase in the frequency of occurrence of an accident previously evaluated in the plant-specific DCD; (2) Result in more than a minimal increase in the likelihood of occurrence of a malfunction of a structure, system, or component (SSC) important to safety previously evaluated in the plant-specific DCD; (3) Result in more than a minimal increase in the consequences of an accident previously evaluated in the plant-specific DCD; 9

4 (4) Result in more than a minimalincrease in the consequences of a malfunction of a SSC important to safety previously evaluated in the plant-specific DCD; (5) Create a possibility for an accident of a different type than any evaluated previously in the plant-specific DCD; (6) Create a possibility for a malfunction (,f an SSC important to safety with a different result than any evaluated previously in the plant-specific DCD; (7) Result in the design basis capability for any SSC directly related to maintaining the integrity of the physical barriers intended to contain radioactivity (including mitigation systems), or any system necessary to support the functions of these SSC, being exceeded or altered; or (8) Result in more than a minimal change in a method of analysis described in the plant-specific DCD that is used to establish design basis values.

d. If a departure requires a license amendment pursuant to paragraphs B.5.b or B.S.c of this section, it is governed by 10 CFR 50.90.

X. Records and Reporting A. Records.

3. An applicant or licensee who references this appendix shall prepara and maintain written evaluations which provide the bases for the determinations required by Section Vill of this appendix. These evaluations must be retained throughout the period of application and for the term of the license (including any period of renewal).

PART 72 - LICENSING REQUIREMENTS FOR THE INDEPENDENT STORAGE OF SPENT NUCLEAR FUEL AND HIGH-LEVEL RADIOACTIVE WASTE

9. The authority citation for Part 72 continues to read as follows:

AUTHORITY: Secs. 51,53,57,62,63,65,69,81,161,182,183,184, if 8,187,189,68 Stat. 929, 930, 932, 933, 911, 435. 948, 953, 954, 955, as amenh, see 23,83 Stat. 444, as 10

I 0 amended (42 U.S.C. 2071, 2073, 2077, 2092, 2093, 2095, 2099, 2111, 2201, 2232, 2233, 2234, 2236,2237,2238,2282); sec. 274, Pub. L. 86-373,73 Stat. 688, as amended (42 U.S.C. 2021); I sec 201, as amended,202,206,88 Stat.1242, as amended, 1244,1246 (42 U.S.C. 5841, 1 5842, 5846); Pub. L. 95-601, sec.10, 92 Stat. 2951 (42 U.S.C. 5851); sec.102, Pub. L. 91-190, l 83 Stat. 853 (42 U.S.C. 4332); Secs.131,132,133,135,137,141, Pub. L. 97-425, 96 Stat. 2229,2230,2232,2241, eec.148, Pub. L.100-203,101 Stat.1330-235 (42 U.S.C.10151, 10152,10153,10155,10157,10161,10168). l Section 72.44(p) also issued under secs.142(b) and 148(c), (d), Pub. L. 100-203,101 Stat.1330-232,1330 236 (42 U.S.C.10162(b),10168(c), (d)). Section 72.46 also issued under sec.189, 68 Stat. 955 (42 U.S.C. 2239); sec.134, Pub. L. 97-425, 96 Stat. 2230 (42 U.S.C. 10154). Section 72.96(d) also issued under sec.145(g), Pub. L.100-203,101 Stat.1330-235 (42 U.S.C.10165(g)). Subpart J also issued under secs. 2(2),2(15),2(19),117(a),141(h), Pub. L. 97-425, 96 Stat. 2202, 2203, 2204, 2222, 2224 (42 U.S.C.10101,10137(a),10161(h)). Subparts K and L are also issued under sec.133, 98 Stat. 2230 (42 U.S.C.10153) and sec. 218(a),96 Stat. 2252 (42 U.S.C.10198).

10. Section 72.3 is amended by revising the definition for indeoendent spent fuel storace installation or ISFSI to read as follows:

1 6 72.3 Definitions. l Independent spent fuel storage installation orISFSI means a complex designed and constructed for the interim storage of spent nuclear fuel and other radioactiva materials associated with spent fuel storage. An ISFSI which is located on the site of another facility licensed under this part or a facility licensed under part 50 of this chapter and which shares common utilities and services with such a facility or is physically connected with such other l facility may still be considered independent. l l

11. In Section 72.9, paragraph (b) is revised to read as follows:

11 l

o + $ 72.9 Information collection requirements: OMB approval. (a) * (b) The approved information collection requirements contained in this part appear in $$ 72.7, 72.11, 72.16, 72.19, 72.22 through 72.34, 72.42, 72.44, 72.48 through 72.56, 72.62, 72.70 through 72.82, 72.90, 72.92, 72.94, 72.98, 72.100, 72.102, 72.104, 72.108, 72.120, 72.126,72.140 through 72.176,72.180 through 72.186,72.192,72.206,72.212,72.216,72.218, t 72.230, 72.232, 72.234, 72.236, 72.240, 72.244, and 72.248.

12. In 9 72.24, paragraph (a) is revised as follows:

1 $ 72.24 Contents of application: Technicalinformation. (a) A description and safety assessment of the site on which the ISFSI or MRS is to be located, with appropriate attention to the design bases for extemal events. Such assessment must contain an analysis and evaluation of the major structures, systems and imponents of the ISFSI or MRS that bear on the suitability of the site when the ISFSI or MRS is op erated at its design capacity. If the proposed ISFSI or MRS is to be located on the site of a nLclear power plant or other licensed facility, the potential interactions between the ISFSI or MRS and such other facility-including shared common utilities and services-must be evaluated.

13. Section 72.48 is revised to read as follows:

$ 72.48 Changes, Tests and Experiments. (a) Definitions for the purposes of this section: (1) Change means a modification or addition to, or removal from, the facility or spent fuel storage cask design or procedures that affects a design function, method of performing or controlling the function, or an evaluation that demonstrates that intended functions will be accomplished. 12

(2) The facility or spent fuel storage cask design as described in the Final Safety Analysis Report (FSAR) (as updated) means: (i) The systems, structures, and components (SSC) that are described in the FSAR (as updated), (ii) The design and performance requirements for such SSCs described in the FSAR (as updated), and (iii) The evaluations or methods of evaluation included n the FSAR (as updated) for such SSCs which demonstrate that their intended function (s) will be accomplished. (3) Final Safety Analysis Report (as updated) means: (i) For site-specific licensees, the Safety Analysis Report for a facility submitted in accordance with 5 72.24, as amended and supplemented, and as updated in accordance with 9 72.70; (ii) For general licensees, the Safety Analysis Report for a spent fuel storage cask design, as amended and supplemented; and (iii) For ceitificate holders, the Safety Analysis Report for a spent fuel storage cask design suomitted in accordance with 6 72.230, as amerJed and supplemented, and as updated in accordance with 6 72.248.- (4) Proceduros as described in the Final Safety Analysis Report (as updated) means those procedures that contain information described in the FSAR (as updated) regarding how SSCs are operated and controlled (including assumed operator actions and response times). (5) Tests or experiments not described in the Final Safety Analysis Report (as updated) means any activity where any SSC is utilized or controlled in a manner which is either: (i) Outside the reference bounds of the design bases as described in the FSAR (as updated) or (ii) Inconsistent with the analyses or descriptions in the FSAR (as updated). (6) Facility means eithe: an ISFSI or an MRS. (b) This section applies to: (1) each holder of a license issued under this part, and (2) each holder of a Certificate of Compliance (CoC) issued under this part. (c)(1) A licensee or certificate holder may make changes in the facility or spent fuel storage cask design as described in the FSAR (as updated), make changes in the procedures 13 l l

l as describad in the FSAR (as updated), and conduct tests or experiments not described in the FSAR (as updated), without obtaining either (A) a license amendment pursuant to $ 72.56 (for specific licensees) or (B) a CoC amendment pursuant i; /r 72.244 (for general licensees and certificate holders)if: (i) A change to the technical specifications incorporated in the specific license is not required; or (ii) A change in Q ierms, conditions, or specifications incorporated in the CoC is not required; and j (iii) The change, test, or experiment does not meet any of the criteria in paragraph (c)(2) of this section. (2) A specific licensee shall obtain a license amendment pursuant to 9 72.56 and a general licensee or certificate holder shall obtain a CvC amendment pursuant to 9 72.244, prior to implementing a change, test, or experiment if the change, test, or experiment would: (i) Result in more than a minimal increase in the frequency of occurrence of an accident ~ previously evaluated in the FSAR (as updated); (ii) Result in more than a minimal increase in the frequency of likelihood of a malfunction of a system, structure or component (SSC) important to safety previously eva'uated in the FSAR (as updated); l (iii) Result in more than a minimalincrease in the consequences of an accdont previously evaluated in the FSAR; (iv) Result in more than a minimal increase in the consequences of a malfunction of an SSC important to safety previously evaluated in the FSAR (as updated); (v) Create the possibility for a accident of a different type than any evaluated previously in the FSAR (as updated); (vi) Create the possibility for a malfunction of an SSC important to safety with a different result than any evaluated previously in the FSAR (as updated); (vii) Result in the design basis capability for any SSC directly related to maintaining the integrity of the physical barriers intended to contain radioactivity (including mitigation systems), or any system necessary to support the functions of these SSC, being exceeded or altered; or (viii) Result in more than a minimal change in a method of analysis described in the final safety analysis report (as updated) that is used to estabish design basis values. 14

-4, (3) in implementing tnis paragraph, the FSAR (as updated) is considered to include evaluations performed pursuant to this section and analyses performed pursuant to $$ 72.56 or 72.244 after the last update of the FSAR pursuant to $$ 72.70, or 72.248 of this part. (4) The provisions in this section do not apply to changes in the facility or spent fuel i storage cask design or procedures when the applicable regulations establish more specific criteria for accomplishing such changes. (d)(1) The licensee and certificate holder shall maintain records of changes in the facility or spent fuel storage cask design, of changes in procedures, and of tests and experiments made pursuant to paragraph (c) of this section. These records must include a written evaluation which provides the bases for the determination that the change, test, or experiment does not require a license or CoC amendment pursuant to paragraph (c)(2) of this section. (2) The licensee and cedificate holder shall submit, as specified in f 72.4, a report containing a brief description of any changes, tests, and experiments, including a summary of the evaluation of each. A report shall tea submitted at intervals not to exceed 24 months. (3) The records of changes in the facility or spent fuel storage cask design shall be maintained until: (i) spent fuel is no longer stored in the facility or using the spent fuel storage cask design, or (ii) the Commission terminates the license or CoC issued pursuant to this part. (4) The records of changes in procedures and of tests and experiments shall be maintained for a period of five years. (5) The holder of a spent fuel storage cask design CoC, who permanently ceases operation, shall provided the records of changes to the new certificate holder or to the Commission, as appropriate, in accordance with 9 72.234(d)(3). (6)(i) A general licensee shall provide a copy of the record for any changes to a spent fuel storage cask design to the applicable certificate holder vdhin 30 days of implementing the change. (ii) A specific licensee using a spent fuel storage cask design, approved pursuant to subpart L of this part, shall provide a copy of the record for any changes to a spent fuel storage cask design to the wplicable certificate holder within 30 days of implementing the change. 15

4 es (iii) A certificate bolder shall provide a copy of the record for any changes to a spent fuel storage cask design to any general or specific licensee using the cask design within 30 days of

implementing the change.

(iv) A licensee or certificate holder receiving a record of such changes shall review the record within 60 days for Lpplicability to its facility or cask dr <.gn, respectively. .14. Section 72.56 is revised to read as follows: $72.56 Application for amendment of license. Whenever a holder of a specific license desires to amend the license (including a change to the license conditions), an application for an amendment shall be filed with the Commission fully describing the changes desired and the reasons for such changes, and following as far as applicable the form prescribed for original applications.

15. Section 72.70 is revised to read as follows:

$ 72.70 Safety analysis report updating. (a) Each licensea for an ISFSI or MRS shall update periodically, as provided in paragraphs (b) and (c) of this section, the fine! safety analysis report (FSAR) to assure that the information included in the report contains the latest information developed. (1) The licensee shall submit an original FSAR to the Commission, in accordance with 9 72.4, within 90 days after issuance of the license. (2) The original FSAR shall be based on the safety analysis report submitted with the application and reflect any changes and applicant commitments developed during the license approval and/or hearing process. (b) Each update shall contain all the changes necessary to reflect information and analyses submitted to the Commission by the licensee or prepared by the licensee pursuant to Commission requirement since the submission of the original FSAR, or as appropriate the last update to the FSAR under this section. The update shall include the effects' of: (1) All changes made in the ISFSI or MRS or procedures as described in the FSAR; 16

e 0 (2) All safety analyses and evaluations performed by the licensee either in support of approved license amendments, or in support of conclusions that changes did not require a license amendment in accordance with 6 72.48(c)(2); (3) All final analyses and evaluations of the design and performance of structures, 4 systems, and components that are important to safety taking into account any pertinent information developed during final design, construction, and preoperational testing; and (4) All analyses of new safety issues performed by or on behalf of the licensee at Commission request. The information shall be appropriately located within the updated FSAR. (c)(1) The update of the FSAR shall be filed in accordance with 9 72A, on a replace,nent-page basis; (2) The update shell include a list of effective pages, indicating the current revision for each page; j (3) Each replacement page shall include both a change indicator for the area changed, e.g., a bold line vertically drawn in the margin adjacent to the portion actually changed, and a page change identification (date of change or change number or both); (4) The update shall include (i) a certification by a duly authorized officer of the licensee that either the information accurately presents changes made since the previous submittal, or that no such changes were made; and (ii) an identification of changes made under the provisions of 5 72.48, but not previously submitted to the commission; (5) The update shall reflect all changes up to a maximum of 6 months prior to the date of filing; and (6) Updates shall be filed every 24 months from the date of issuance of the license. (d) The updated FSAR shall be retained by the licensee until the Commission terminates the I; cense. ' Effects of changes includes appropriate revisions of descriptions ia the FSAR such that the FSAR (as updated) is complete and accurate. 17

a.-

16. In 9 72.80, paragraph (g) is added to read as follows:

$ 72.80 Other records and reports. (g) Each specific licensee shall notify the Commission, in accordance with $ 72.4, of its readiness to begin operation at least 90 days prior to the first storage of spent fuel or high-level waste in an ISFSI or MRS.

17. In $ 72.86, paragraph (b) is revised to read as follows:

$ 72.86 Criminal penalties. (b) The regulations in part 72 that are not issued under sections 161b,1611, or 161o for the purposes of section 223 are as follows: $$ 72.1,72.2,72.3,72.4,72.5,72.7,72.8,72.0, 72.16,72.18,72.20,72.22,72.24,7?.26,72.28,72.32, 72.34,72.40,72.46,72.56,72.58,72.60, 72.62,72.84,72.86,72.90,72.96, 71.',08,72.120,72.122,72.124,72.126,72.128,72.130, 72.182,72.194,72.200,72.202,72.204, 72.206,72.210,72.214, 72.220,72.230, 72.238, 72.240,72.244, and 72.246.

18. In $ 72.212, paragraphs (b)(2) and (4) are revised to read as follows:

$ 72.212 Conditions of general license issued under $ 72.210. (b) (2)(i) Perform written evaluations, prior to use, that establish that (A) conditions set forth in the Certificate of Compliance have been met; (B) cask storage pads and areas have been designed to adequately support the stetic load of the stored casks; and (C) the requirements of f 72.104 have been met. A copy of this record shall be retained until spent fuelis no longer stored under the general licensa issued under 9 72.210. 18

4 (ii) The licensee shall evaluate any changes to the written evaluations required by this subparagraph using the requirements of $ 72.48(c). A copy of this r, cord shall be retained until spent fuel is no longer stored under the general license issued under } 72.210. (4) Prior to use of this general license, determine whether ac 4. ties related to storage of spent fuel under this general license involve a chango in the facility. echnical Specifications or require a license amendment for the facility pursuant to $ 50.59(c)(2) of this chapter. Results of this determination must b6 documented in the evaluation made in paragraph (b)(2) of this section.

19. In $ 72.216, paragraph (d) is added to read as follows:

(Proposed rule is withdrawn) i

20. Section 72.244 is added to read as fellows:

$72.244 Application for amendment of a certificate of compliance. l I 4 Whenever a certificate holder desires to amend the CoC (including a change to the j to mis, conditions or specifications of the CoC), an application for an amendment shall be filed with the Commission fully describing the changes desired and the reasons for such changes, and following as far as applicable the form prescribed for original applications.

21. Section 72.246 is added to read as follows:

$72.246 Issuance of amendment to a certificate of compliance. In determining whether an amendment to a CoC will be issued to the applicant, the Commission will be guided by the considerations that govem the issuance of an initial CoC.

22. Section 72.248 is added to read as follows:

19

4 e f 72.248 Safety analysis report updating. (a) Each certificate holder for a spent fuel storage cask design shall update periodically, as provided in paragraph (b) of this section, the final safety analysis report (FSAR) to assure j that the informatior: included in the report contains the latest information developed. (1) The certificate holder shall submit an original FSAR to the Commission, in accordance with $ 72 A cithin 90 days after the spent fuel storage cask design has been 4 approved pursuant to 9 72.238. (2) The original FSAR shall be based on the safety analysis report submitted with the application and reflect any changes and applicant commitments developed during the cask design review process. The original FSAR shall be updated to reflect any changes to requirements contained in the issued Certificate of Compliance (CoC) and information contained in the NRC staff's safety evaluation report (SER) for the cask design. However, the entire CoC and SER need not be directly inserted into the FSAR. (b) Each update shall contain all the changes necessary to reflect information and analyses submitted to the Commission by the certificate holder or prepared by the certificate holder pursuant to Commission requirement since the submission of the original FSAR, or as appropriate the last update to the FSAR under this section. The update shall include the effects' of: (1) All changes raade in the spent fuel storage cask design or procedures as described in the FSAR; (2) All safety analyses and evaluations performed by the certificate holder either in support of approved CoC amendments, or in support of conclusions that changes did not require a CoC amendment in accordance with 9 72.48(c)(2); and (3) All analyses of new safety issues performed by or on behalf of the certificate holder at Commission request. The information shall be appropriately located within the updated FS?P.. 1 (c)(1) The update of the FSAR shall be filed in accordance with 9 72.4, on a replacement-page basis; (2) The update shall include a list of effective pages, indicating the current revision for each page; 20

o \\ (3) Each replacement page shall include both a change indicator for the area changed, e.g., a bold line vertically drawn in the margin adjacent to the portion actually changed, and a page change identification (date of change or change number or both); (4) The update shall lnclude (i) a certification by a duly authorized officer of the certificate holder that either the informaton accurately presents changes made since the previous submittal, or that no such char.ges were made; and (ii) an identification of changes made under the provisions of f 72.48, but not previously submitted to the Commission; (5) The update shall reflect all changes up to a maximum of 6 months prior to the date of filing; (6) Updates shall be filed every 24 months from the date of issuance of the CoC; and (7) The certifierate holder shall provide a copy of the updated FSAR to each general and specdic licensee using its cask design. (d) The updated FSAR shall be retained by the certificate holder until the Commission terminates the certificate. (e) A certificate holder who permanently ceases operation, shall provided the updated FSAR to the new certificate holder or to the Commission, as appropriate, in accordance with 5 72.234(d)(3). 1 ' Effects of changes includes appropriate revisions of descriptions in the FSAR such that i i the FSAR (as updated) is complete and accurate. 21 t ]

.,s. 1 ATTACHMENT 3: OTHER RULE LANGUAGE CHANGES AND ISSUES 'l i i l

y e OTHER RULE LANGUAGE CHANGES AND ISSUES in addition to the topics discussed in the paper, the staff is providing this discussion of other aspects of the rule that have resulted in changes to the rule language, or that were requested by the Commission. In addition, the staff notes that the comment discussion in Attachment 1 to the paper contains more details on suggested rule language changes and other issues brought forth by the comment letters. Definitions - A number of comments were received on the definitions, and as a result, certain clarifying changes were made as reflected in the attached draft rule language. One of the more significant changes to definitions was that for " change." This definition is discussed in more detail below. Change to the facility as described in the final safety analysis report (as updated) in the proposed rule, NRC recommended that the word " change," as written in the existing requirements, be understood to mean the modification of an existing provision (e.g., systems, structures, or components (SSCs); procedures; design requirements; analysis methods or parameters); additions (e.g., new SSCs or procedural stsps); and removals from the facility (physical removals or retirement in place or non-reliance on a system to meet a requirement). Further, the supplementary information for the proposed rule stated that enanges to evaluative methods, acceptance standards, or other information for an SSC described in the FSAR is also i a change to the facility as described. Therefore, the proposed rule included definitions of " change" and of " facility as described in the safety analysis report (as updated)," as well as for procedures as described. Several commenters stated that revisions were needed to the proposed definitions to allow greater use of screening of proposed changes, that is, for licensees to determine that certain - proposed changes to the facility do not require evaluation against the regulatory criteria in 9 50.5g. Otherwise, the commenters were concemed that even such additions as identification tags or light bulbs might require evaluation under the rule. Thus, they proposed that the definition of" change' be modified by the addition of the highlighted phrase: "a change is a modification, addition or removal that affects a design function, method of perfonning or controlling the function, or an evaluation that demonstrates that intended functions will be accomplished." This approach would allow certain changes to be made without requiring the review and documentation process for a 9 50.59 evaluation. In practice, the industry uses a two-step process in reviewing chaages to its facilities. Step one is a review of the proposed change to determine if it meets the " scope" criteria for review (contained in proposed rule $ 50.59(c)(1)), otherwise known as a " screening review." If the change falls within these defin4 ions, an evaluation against the criteria in 9 50.59(c)(2) would be performed. The staff recognizes that many of the changes being made at a facility are such that a licensee could readily determine that the change does not affect the facility, and would never involve any of the evaluation c, Ceria, and, thus, could be screened out, provided the rule language accommodates such an approach. The ruggested rule language would :odify screening of changes in the regulations. Such clarifications to the definitions wouk'significantly I reduce the number of evaluations that need to be performed and therefore would re 'uce

I-1 4 9 licensee burden. There is some potential for changes to be mistakenly screened out as not affecting functions and, thus, as not requiring an evaluation. Since the rule does not explicitly require dxumentation of screening, opportunities to correct such errors may be limited. In practice, records of screenings are typically prepared and maintained, as discussed in NEl 96-

07. Accordingly, the staff views the potential for undetected errors to be small, and the rule change would provide much greater flexibility and reduce the licensee burden for preparing evaluations for changes that do not warrant such review. Staff also believes that staff burden to i

inspect and review $ 50.59 evaluations would be reduced, thereby allowing staff to focus l attention on more significant changes. This approach will require some revisions to existing guidanca such as NEl 96-07 especially with respect to how to appropriate screen changes that may affect functions. Staff recommends adopting the NEl proposal in this area to codify the use of a screening process Staff plans to supplement existing staff guidance and NEl 96-07 guidance to provide greater assurance that screening activities will be appropriately conducted and documented. Definition of accident, or design basis accident of a different type The proposed rule included as a criterion for prior approval if a change, test, or experiment would " create the possibility for a design basis accident of a different type than any evaluated previously in the final safety analysis report (as updated) or in evaluations...." The FR notice suggested a definition of " accident" and requested comment as to whether a definition was needed and on the language offered in the notice. Most commenters stated that a definition of " accident" was not needed in the rule but could be discussed in guidance. A few commenters offered attemative definitions for " accident" or more specifically, " accident of a different type." Several agreed with the premise that only " design basis" accidents were to be considered, distiaguishing these from the spectrum of accidents typically considered in a PRA and from incredible accidents that might be created as a result of a change. Minor changes to NEl 96-07 may be useful to clarify understanding of accident of a different type. Staff does not recommend adding a definition of " accident" or using the terminology of " design basis accident of a different type"in the rule. The staff concludes that a suitable definition for accident previously evaluated in the FSAR, that would be included in guidance, is the following: Accident previously evaluatedin the FSAR (as updated) means an accident described in the final safety analysis report (as updated) including accidents such as those traditionally found in Chapter 15 of the final safety analysis report, and those accidents described in the final safety analysis report dealing with floods, fires, seismic events, other extemal hazards, water-solid over pressure, anticipated transient without scram, and station blackout. Consequences of an accident or malfunction of equipment important to safety previously evaluated in the FSAR (as updated) are more than minimally increased ($$50.59 (c)(2)(lii) and (c)(2)(iv)) In addition, the proposed rule included language that would permit a minimal increase in consequences. To assist in implementation, the supplementary information for the proposed rule included options for guidance to explain how "a minimal increase" shoud be applied. One of the options offered by staff was that minimal increases woud correspond to a fraction (i.e., 1

t G o. I 10%) of the difference between the FSAR calculated value and the applicable acceptance guidelines (regulatory values or Standard Review Plan values as applicable). During the comment period, NEl proposed that the staff's guidance be modified such that there is no more than a minimal increase in (radiological) consequences if the increase is less than or equal to 10 percent of the difference between the FSAR calculated values and the guidelines established in the regulations (e.g., Part 100 or Part 50 General Design Criterion 19), but also if the increase did not exceed any other acceptance guidelines (if applicable). While NEl acknowledged staff's concems about changes being made without review that would approach the regulatory guidelines, it also believes that the guidelines in the SRP that establish acceptance criteria of "small fraction of Part 100 limits" for particular events already provide sufficient regulatory control such that licensees should not be restricted from increases up to these values. Some commenters thought 20% was a more reasonable fraction of the difference j to specify as minimal. Still other commenters favored allowing increases up to regulatory limits (without use of a term such as minimal increase), believing that the " consequences previously evaluated" includes the limits that were used as the basis for the licensing determination ) The staff agrees that establishing controls on the margin to the SRP guidelines is not necessary, and, thus, proposes to revise its guidance on interpretation of " minimal" increases to make tis t clarification. The staff's proposal will require some revisions to NEl 96-07 to explain the use of differences to regulatory guidelines, and the role of other guidelines such as SRP values. Thus, the staff would agree that there is no more than a minimal increate in consequences if the increase is less than or equal to 10% of the difference between the calculated value and the regulatory guidelines, or as long as the SRP guidelines are met, with the clarification that the SRP guidelines form a basis of minimal increase for all facilities, not just those that were specifically reviewed against its guidelines. This clarification will be discussed in the implementation guidance. Reporting and Recordkeeping Requirements ($ 50.71(e)) For reporting, the NRC proposed to revise the reporting requirement in $ 50.71(e) to require licensees to provide information to enable the staff to monitor potential cumulative impacts for " minimal" increases. Specifically, the proposed rule would interpret the phrase " effects of" to include, for purposes of the FSAR update report, the effects on probabilities and consequences. This proposal elicited strong opposition. Many commenters stated that this proposal would sign;ficantly increase licensee burden, that it was not necessary since the rule would limit the amount of change to " minimal" increases that were insignificant with respect to the licensing 4 basis, and, therefore, that the proposal should not be implemented. As noted by many of the commenters, assessments of probabilities are generally qualitative and would thus be difficult to report on with respect to cumulative effects. Where analyses are revised to document the effects of changes (involving consequences, or " margins"), the existing language would require the FSAR to reflect the effects of these changes. Further, the way that "tr%imal" is defined prevents even multiple changes from exceeding limits. The staff recommends scmptance of these comments and proposes to drop the rule language that would require explicit documentation of cumulative effects as part of the update requirements.}}